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U.S. Department of Health and Human Services

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Enforcement Report for November 16, 2005

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

November 16, 2005
05-46

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

______________________________
PRODUCT
FORTUNE STAR brand WHITE FUNGUS, Net Wt. 3 oz. (85g). PRODUCT OF CHINA. Serving Size 3 oz. (85 g) The product is packaged in a sealed plastic bag. UPC barcode # 6 644601 04083, Recall # F-021-6
CODE
All products on the market at the time of recall.
RECALLING FIRM/MANUFACTURER
Recalling Firm: HO's Trading INC, Brooklyn, NY, press release on July 1, 2005 followed by letters dated July 1, 2005.
Manufacturer: Sinojet Development Ltd. Hong Kong, China. New York State initiated recall is complete.
REASON
The product contained undeclared sulfites (2690 ppm) based on sampling & analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
37 cases (100 -- 3 oz. packages per case)
DISTRIBUTION
Nationwide.

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PRODUCT
Ocean Pearl**KEEP FROZEN***Wild Caught***Clam Meat Fully Cooked Individually Quick Frozen***Size: 300/500***NET WT. 1LB (16OZ)***Product of China***packed 24 1 pound packages to a case, Recall # F-022-6
CODE
Bar code: 8 23998 12923 8 on 1 pound packages; Lot C7397 on master cartons
RECALLING FIRM/MANUFACTURER
Recalling Firm: Yu I Hsiang U.S.A. Corp. Dba Fortuna Seafoods, Rosemead, CA, by telephone, fax and letter on September 27, 2005.
Manufacturer: Fujian Provincial Meihua Aquatic Processing Factory, Changle, China. FDA initiated recall is ongoing.
REASON
Clam meat is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
782 cases
DISTRIBUTION
CA and NY

_______________________________
PRODUCT
PEONY MARK brand DRIED DATE --- Ing: Date --- NET WT:12oz (340g) --- Ing: Date --- PRODUCT OF CHINA --- Serving Size 1 plate (340g) --- Servings Per Container 6 ---- The product is packed in a sealed plastic package. UPC bar code # 6 86529 13005 5, Recall # F-023-6
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Starway Inc., Brooklyn, N.Y., by press release and letters dated September 16, 2005.
Manufacturer: JiangmenCity Xinhui Cheung Yue Foodstuffs Industry Ltd. Guangdong, China. New York state initiated recall is complete.
REASON
The product contained undeclared sulfites (118 ppm) based on routine sampling and analysis by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
107 cases (50 packages per case)
DISTRIBUTION
NY

_______________________________
PRODUCT
Home Made Brand Tuna Salad, Net Wt. 5 lb units. Recall # F-024-6
CODE
Use By Date: 10/16
RECALLING FIRM/MANUFACTURER
Home Made Brand Foods Co., Inc., Newburyport, MA, by press release, fax and letters on October 14, 2005 and corrected press release on October 21, 2005. New York State initiated recall is ongoing.
REASON
The product may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
398/5 lbs.
DISTRIBUTION
MA, ME and NY

 

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II

______________________________
PRODUCT
Sabritas Cacahuates Peanuts Sabor Picante Spicy Flavored. Net wt. 1 3/4 oz. (49.6 g) Fabricado Para, UPC codes 32952 (case), 04129 (bag), 04196 (caddie), and 04197 (shipper) Recall # F-020-6
CODE
All lots and all codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Frito-Lay, Inc., Plano TX, by e-mail and by fax on October 3, 2005.
Manufacturer: J B Sanfilippo And Son, Elk Grove Village, IL. Firm initiated recall is ongoing.
REASON
The product contains undeclared colors - FD&C Red 40 Lake and FD&C Yellow 6 Lake.
VOLUME OF PRODUCT IN COMMERCE
280,000 units
DISTRIBUTION
Nationwide
 

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

_______________________________
PRODUCT
Olive Olea Europaea Allergenic Extract, Contains: 0.2% Phenol, 50% v//v Glycerin, 10mL 1:20 W/V Sterile Multiple Dose Vial, Rx only, Recall # D-018-6
CODE
Lot # 27685, Item number G123A02
RECALLING FIRM/MANUFACTURER
Greer Laboratories, Inc., Lenoir, NC, by telephone and letter on October 13, 2005. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility; the vials may leak due to the possibility of a faulty seal.
VOLUME OF PRODUCT IN COMMERCE
10 vials
DISTRIBUTION
AZ, CA, and FL

_______________________________
PRODUCT
Ipratropium Bromide Inhalation Solution, 0.02% (0.5mg/vial), 1 Foil pouch with 30 sterile 2.5 mL Unit-Dose Vials per pouch, For oral inhalation only, Rx only, NDC 0487-9801-30, Recall # D-020-6
CODE
Lot Number: P5013A, Expiration Date: December 2006
RECALLING FIRM/MANUFACTURER
Nephron Pharmaceuticals Corp., Orlando, FL, by letter on September 15, 2005. Firm initiated recall is ongoing.
REASON
Mispacked; pouches labeled to contain Ipratropium Bromide actually contain Albuterol Sulfate Inhalation Solution 0.083%.
VOLUME OF PRODUCT IN COMMERCE
12,452 cartons of 30 vials in a foil pouch
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

_______________________________
PRODUCT
Ketoconazole Shampoo, 2%, packaged in 4 fl. oz. plastic bottle, Rx only, For topical application only, NDC 0781-7090-04, Recall # D-019-6
CODE
Lot number: 1951
RECALLING FIRM/MANUFACTURER
QLT USA, INC., Fort Collins, CO, by e-mail on October 14, 2005. Firm initiated recall is ongoing.
REASON
Subpotent (6 month stability)
VOLUME OF PRODUCT IN COMMERCE
9,145 bottles
DISTRIBUTION
CO
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0059-6
CODE
Unit number: 6871879
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile dated February 6, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-0078-6
CODE
Unit numbers: 12W82020 (2-unit split), 12LT52752
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on October 10, 2003 and by letter on November 5, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC

_______________________________
PRODUCT
Source Plasma, Recall # B-0079-6
CODE
Unit numbers: 0161196, 0161568
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Farmington, NM, on January 17, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo applied within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0082-6;
b) Cryoprecipitated, AHF, Recall # B-0083-6;
c) Recovered Plasma, Recall # B-0084-6
CODE
a), b), and c) Unit number 50LJ6517
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by facsimile on January 23, 2004 and by letter on January 26, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OH and Switzerland

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0093-6
CODE
Unit number: 6600558
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on January 20, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

______________________________
PRODUCT
Red Blood Cells, Recall # B-0107-6
CODE
Unit number: 7015334
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 21, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0109-6
CODE
Unit number: 6446070
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 22, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0110-6
CODE
Unit number: 6827154
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on January 16, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0111-6
CODE
Unit number: 6529429
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on January 20, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocyte Reduced, Recall # B-0112-6
CODE
Unit number: 6529389
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on January 20, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Leukocyte Reduced, Recall # B-0124-6
CODE
Unit numbers: 13FV21747, 13GV40788
RECALLING FIRM/MANUFACTURER
American Red Cross, Southern Michigan Region, Detroit, MI, by telephone on May 13, 2004, and by letter dated May 19, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to human T-lymphotropic virus type I/II (anti-HTLV-I/II), but were collected from a donor who previously tested repeatedly reactive for anti-HTLV-I/II, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI

______________________________
PRODUCT
Source Plasma, Recall # B-0126-6
CODE
Unit numbers: AB0849380, AB0850550, AB0851162, AB0851385, AB0852130, AB0852363, AB0853199, AB0853459, AB0854269, AB0854541, AB0855627, AB0856342, AB0856536, AB0857489, AB0857755, AB0858421, AB0858705, AB0859613, AB0859882, AB0860718, AB0861010, AB0861651, AB0862004, AB0862672, AB0862894, AB0863535, AB0863817, AB0864419, AB0864877, AB0865870, AB0866479, AB0867255, AB0867676, AB0868316, AB0868623, AB0869393, AB0869722, AB0870384, AB0870845, AB0871432, AB0871747, AB0872840, AB0873062, AB0874025, AB0874230, AB0875006, AB0875338, AB0876056, AB0876323, AB0876915, AB0877210, AB0877913, AB0878265, AB0878972, AB0879203, AB0880030, AB0880299, AB0881079, AB0881539, AB0882026, AB0882543, AB0882992, AB0883487, AB0883963, AB0884547, AB0884985, AB0885329, AB0886016, AB0886487, AB0886937, AB0887401, AB0888021, AB0888514, AB0888901, AB0889328, AB0889801, AB0890390, AB0890847, AB0891449, AB0891887, AB0893016, AB0893354, AB0893937, AB0894376, AB0894950, AB0896187, AB0896451
RECALLING FIRM/MANUFACTURER
Bio-Save Resources of Albuquerque LLC, Albuquerque, NM, by facsimile on January 8, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
87 units
DISTRIBUTION
England

______________________________
PRODUCT
ETI-LAB Applications Disk (for programming Bio-Rad HIV-1/HIV-2 Plus O EIA Assay), Recall # B-0140-6
CODE
Version 1.0
RECALLING FIRM/MANUFACTURER
Diasorin, Inc., Stillwater, MN, by telephone and letter dated May 13, 2004. Firm initiated recall is complete.
REASON
Defect in the design of HIV-1/2 testing software resulting in an incorrect incubation temperature.
VOLUME OF PRODUCT IN COMMERCE
11
DISTRIBUTION
MA, NY, MT, AL, MS, SD, LA, and CT

______________________________
PRODUCT
Source Plasma, Recall # B-0149-6
CODE
Unit numbers: 24103589, 24103144, 24102561, 24102143, 24101621, 24101241, 24093439, 24093023, 24092430
RECALLING FIRM/MANUFACTURER
Ohio Blood Plasma, Inc, Cincinnati, OH, by facsimile on June 1, 2005. Firm initiated recall is complete.
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
NC

______________________________
PRODUCT
Human Cornea for Transplantation, Recall # B-0151-6
CODE
Tissue 05-0048-100
RECALLING FIRM/MANUFACTURER
Oklahoma Lions Eye Bank, Oklahoma City, OK, by telephone on July 25, 2005, and by letter dated August 8, 2005. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior to distribution but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBcore) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
OK

______________________________
PRODUCT
Red Blood Cells, Recall # B-0153-6
CODE
Unit number: 5852368
RECALLING FIRM/MANUFACTURER
Life Source, Glenview, IL, by telephone on July 12, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

______________________________
PRODUCT
Red Blood Cells, Recall # B-0155-6
CODE
Unit number: X22036
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated June 6, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0156-6;
b) Platelets, Recall # B-0157-6
CODE
a) and b) Unit number: 2076958
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated April 6, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0158-6
CODE
Unit number: 042KW24944
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on May 17, 2005, and by letter dated May 20, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0057-6
CODE
Unit numbers: 3147176, 3147312, 3145668
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on May 28, 2003. Firm initiated recall is complete.
REASON
Red Cells, lacking proper documentation of antigen phenotyping, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0077-6
CODE
Unit numbers: 06LW78976, 06LW78978, 06LW78981, 06GX38981, 06GX38983, 06GX38984, 06GX38985, 06FS79436, 06GG61847, 06GG61846
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern California Region, Pomona, CA, by telephone on July 29, 2003, by fax on August 3, 2004 and by letter dated August 4, 2004. Firm initiated recall is complete.
REASON
Blood Products, which may have been exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Source Plasma, Recall # B-0088-6
CODE
Unit numbers: 0814904, 0815839, 0818938, 0819436, 0820974, 0821296, 0822917, 0823214, AB0826584, AB0826866, AB0827715, AB0827965, AB0828694, AB0828950, AB0829718, AB0829925
RECALLING FIRM/MANUFACTURER
Bio-Save Resources of Albuquerque LLC, Albuquerque, NM, on May 15, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
United Kingdom

_______________________________
PRODUCT
Platelets Pheresis Leukoreduced, Recall # B-0113-6
CODE
Unit number: 101968830 (distributed as 2 split products)
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Scottsdale, AZ, by telephone on April 21, 2005. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with coagulase-negative staphyloccus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ

_______________________________
PRODUCT
Panoscreen I, II, III, Recall # B-0123-6
CODE
Lot 37010A, Expiration 25 Sep 03
RECALLING FIRM/MANUFACTURER
Immucor, Inc., Norcross, GA, by letter dated September 19, 2003. Firm initiated recall is complete.
REASON
Panoscreens, packaged with the incorrect Master List, were distributed.
VOLUME OF PRODUCT IN COMMERCE
684
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Fresh Frozen Plasma (Apheresis), Recall # B-0150-6
CODE
Unit number: 210430
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile dated January 17, 1997. Firm initiated recall is complete.
REASON
Fresh Frozen Plasma, not frozen within 6 hours of collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Fresh Frozen Plasma (Apheresis), Recall # B-0152-6
CODE
Unit numbers: 197501, 197767, 202815, 202817, 203439, 203448, 215347
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile dated February 10, 1997. Firm initiated recall is complete.
REASON
Fresh Frozen Plasma, not frozen within 6 hours of collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0154-6
CODE
Unit number: 4718426
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated April 8, 2004. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

 

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

_______________________________
PRODUCT
a) Roche CoaguChek System Controls (patient self testing);
Catalog number 763, Part numbers 054200705 and
047514003, Recall # Z-0098-06;
b) Roche CoaguChek System Controls; Catalog number 7745,
Part numbers 054207608 and 04393201001,
Recall # Z-0099-06;
c) Roche CoaguChek S System Controls; Catalog number
3033384, part numbers 010018501 and 04393198001,
Recall # Z-0100-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Burlington, NC, by letter dated March 28, 2005. Firm initiated recall is complete.
REASON
Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Lifescan OneTouch SureStep Meter Blood Glucose monitoring system, Recall # Z-0101-06
CODE
The following art numbers (kit configurations) are affected by this recall: 010-341-18(OT SureStep system), 010-341-20 (OT SureStep System), 010-341-52 (OT SureStep starter kit), 010-411-06 (OT SureStepE Meter Warranty), 091-041-106 (OT SureStep Meter Warranty PBK). The following lot numbers are affected: 42711002-01, 42711002-02, 42711002-03, 42731001-01, 42731001-02, 42891003-01, 42901001-01, 42901001-02, 42901001-03, 42911002-01, 42911002-02, 42911002-03, 42921002-01, 42921002-02, 42931001-01, 42931001-02, 42931001-03, 42941001-01, 42941001-02, 42941002-01, 42941002-02, 42941002-03, 42951001-01, 42951001-02, 42951001-03, 42951002-01, 42951002-02, 42951003-01, 42951003-02, 42961001-02, 42961004-01, 42971002-01, 42971002-02, 42971002-03, 42971002-04, 42971002-05, 42971004-01, 42981001-01, 42981001-02, 42981001-03, 42981001-04, 42981001-05, 42981001-06, 42991001-01, 42991001-02, 42991001-03, 43621003-01, 43631001-01, 50051004-01, 50051004-02, 50051004-03, 50061001-01, 50061001-02, 50061001-03, 50081002-01, 50081002-02, 50081002-03, 50091001-01, 50091002-02, 50101001-01, 50101001-02, 50111001-01, 50111002-01, 50121001-01, 50121001-02, 50131001-01, 50131001-02, 50141001-02, 50141001-03, 50171001-04, 50311003-03, 50311003-04, 50321002-01, 50331001-02, 50351002-01, 50351002-02, 50361005-01, 50371001-01, 50371001-02, 50471001-04, 50481001-03
RECALLING FIRM/MANUFACTURER
LifeScan, Inc., Milpitas, CA, by letter and telephone on September 9, 2005. Firm initiated recall is ongoing.
REASON
The LCD of the OneTouch SureStep Meter may display incorrectly, resulting in missing segments on the display. This display failure may result in patients misreading the blood glucose result, or cause a delay in test interpretation, and could cause delays or mistreatment.
VOLUME OF PRODUCT IN COMMERCE
48,554 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Sopha Medical Vision DST / DST-XL Digital variable angle Nuclear Imaging System. Cameras affected by this safety notice are labeled with the SOPHA MEDICAL logo. STATIF DST and STATIF DST-XL model 100. The label is located on the inner side of the gantry cover. All affected cameras were manufactured prior to 1997 by Sopha Medial (SMV), which was subsequently acquired by GE Healthcare in 2000. Recall # Z-0105-06
CODE
Serial numbers 001-264
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Med Systems LLC, Waukesha, WI, by letter dated July 22, 2005.
Manufacturer: Sopha Medical Systems, Inc., Cedex, France. Firm initiated recall is ongoing.
REASON
Cracked welds on the main rotation shaft could potentially lead to the collapse of the gantry yokes that support the detectors.
VOLUME OF PRODUCT IN COMMERCE
140 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Meridian PA Femoral Stem,
Catalog No --Description -- # of Lots: 6261-0-001,
Meridian PA Hip Stem #00/9, 25 lots; 6261-0-002,
Meridian PA Hip Stem #00/10, 26 lots; 6261-0-003,
Meridian PA Hip Stem #1/11MM, 107 lots; 6261-0-004,
Meridian PA Hip Stem #2/10MM, 16 lots; 6261-0-005,
Meridian PA Hip Stem #2/12MM, 109 lots; 6261-0-006,
Meridian PA Hip Stem #3/11MM 150 lots; 6261-0-007,
Meridian PA Hip Stem #3/13MM, 256 lots; 6261-0-008,
Meridian PA Hip Stem #4/12MM, 115 lots; 6261-0-009,
Meridian PA Hip Stem #4/14MM, 194 lots; 6261-0-010,
Meridian PA Hip Stem #5/13MM, 139 lots; 6261-0-011,
Meridian PA Hip Stem #5/15MM, 104 lots; 6261-0-012,
Meridian PA Hip Stem #6/14MM, 96 lots; 6261-0-013,
Meridian PA Hip Stem, #6/16MM, 73 lots; 6261-0-014,
Meridian PA Hip Stem, #7/15MM, 21 lots; 6261-0-015,
Meridian PA Hip Stem, #7/17MM, 25 lots; 6261-0-016,
Meridian PA Hip Stem, #8/16, 16 lots; 6261-0-017,
Meridian PA Hip Stem, #8/18, 15 lots,
Recall # Z-0106-06;
b) Meridian ST Femoral Stem,
Catalog #---Description -- # of lots: 6265-0-005,
Meridian ST Hip Stem #2/12MM, 13 lots; 6265-0-006,
Meridian ST Hip Stem #3/11MM, 3 lots; 6265-0-007,
Meridian ST Hip Stem #3/13MM, 31 lots; 6265-0-009,
Meridian ST Hip Stem, #4/14MM, 4 lots; 6265-0-011,
Meridian ST Hip Stem, no # 15 lots; 6265-0-013,
Meridian ST Hip Stem #6/16MM, 7 lots,
Recall # Z-0107-06;
c) Reliance PF Femoral Stem,
Catalog #---Description---- # of lots: 6265-2-000,
Reliance PF Hip #0/10MM, 386 lots; 6265-2-001,
Reliance PF Hip #1/11MM, 484 lots; 6265-2-002,
Reliance PF Hip #2/12MM, 617 lots; 6265-2-003,
Reliance PF Hip #3/13MM, 692 lots; 6265-2-004,
Reliance PF Hip #4/14MM, 465 lots; 6265-2-005,
Reliance PF Hip #5/15MM, 299 lots; 6265-2-006,
Reliance PF Hip #6/16MM, 184 lots; 6265-2-007,
Reliance PF Hip #7/17MM, 138 lots,
Recall # Z-0108-06;
d) Citation AT Femoral Stem,
Catalog #-- Description-- # of lots: 6265-2-102,
Citation AT Left Hip Stem #2, 11 lots; 6265-2-103,
Citation AT Left Hip Stem #3, 15 lots; 6265-2-104,
Citation AT Left Hip Stem #4, 31 lots; 6265-2-105,
Citaiton AT Left Hip Stem #5, 31 lots; 6265-2-112,
Citation AT Left Hip Stem #2, 1 lot # P4GFD; 6265-2-113,
Citation AT Left Hip Stem #3, 49 lots; 6265-2-114,
Citation AT Left Hip Stem #4 , 27 lots; 6265-2-115,
Citation AT Left Hip Stem #5, 23 lots,
Recall # Z-0109-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on August 24, 2005.
Manufacturer: Stryker Ireland, Ltd., Carrigtohill, Ireland. Firm initiated recall is ongoing.
REASON
The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.
VOLUME OF PRODUCT IN COMMERCE
a) 1,936 units;
b) 71 units;
c) 8,487 units;
d) 207 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
The Lysus® Infusion System - Catheter Interface Cable. The Lysus Infusion System employs high frequency, low power ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) The Lysus® Infusion System consists of three main components, a single use Lysus® Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus® Infusion Catheter System, Part number: 3929-001 Catalog number: 700-10301, Recall # Z-0110-06
CODE
Serial numbers: 10098-012, 10098-011, 10098-055
RECALLING FIRM/MANUFACTURER
Ekos Corp., Bothell, WA, by visits starting on September 21, 2004. Firm initiated recall is complete.
REASON
The 100V board in the catheter interface cable pod failed during use. The PT-3 control unit would not recognize the catheter interface cable.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WA, AZ, and OH

_______________________________
PRODUCT
Lysus® Infusion System - Lysus Drug Delivery Catheter: The Lysus Infusion System employs high frequency, low power ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) The Lysus® Infusion System consists of three main components, a single use Lysus® Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus® Infusion Catheter System. Catalog # & Part #: 500-52112, 3383-002; 500-52124, 3393-004; 500-52124, 3393-006; 500-52150, 3393-007, Recall # Z-0111-06
CODE
Serial #s 040914006-004, 040914006-008, 040914007-006, 040914008-003, 040928003-002, 040928003-005, 040928003-009, 040928004-002, 040928005-004, 040928006-002, 040928006-003, 040928006-006, 041013005-004, 040702005-007, 040702005-008, 040719001-005, 040719001-006, 040913002-001, 040913002-002, 040913002-003, 040914007-002, 040914010-001, 040928004-005, 041013006-014, 040928003-012, 040928003-013, 041013005-006, 041013005-007, 041013006-011, 041013006-017, 040719002-003, 040322001-003, 040322001-006, 040322001-013, 040420001-001, 040420001-002, 040420001-004, 040420001-005, 040420001-006, 040420001-007, 040420001-008, 040420001-009, 040420001-010, 040420001-011, 040702005-001, 040702005-002, 040702006-001, 040702006-002, 040928004-004, 040928005-002, 040928005-005, 040928006-004, 040928006-005, 040702005-003, 040702005-004, 040702006-003, 040702006-004, 040719001-001, 040719001-002, 040719002-002, 040719003-001, 040719003-002, 040914007-005, 040914008-002, 040914009-003, 040928004-001, 040928006-009, 040928006-010, 040928007-002, 040702005-005, 040702005-006, 040702006-005, 040719001-003, 040719001-004, 040909003-001, 040909003-002, 040913002-004, 040913002-005, 040914006-007, 040914007-003, 040914007-004, 040914009-004, 040928003-001, 040928004-008, 040928005-006, 040928006-001, 040928007-001, 041013005-005, 041013006-012, 041013006-013, 041119002-001, 041119003-001, 040719001-007, 040914006-003, 040914007-001, 040914008-001, 040914009-001, 040928003-010, 040928004-006, 040928004-007, 041013004-001, 041013004-002, 041013004-003, 041013006-008, 041013006-015, 040420001-003, 040719001-008, 040719002-001, 040914006-001, 040914006-005, 040914006-006, 040914006-009, 040914006-010, 040914008-004, 040928003-003, 040928003-004, 040928003-011, 040928003-014, 040928004-003, 040928005-007, 040928005-008, 041013006-009, 041013006-016, 041013006-018, 050204002-001, 050204002-002, 050204002-003, 050204002-004, 050204002-005, 050209002-001, 050209002-002, 050209002-003, 050209002-004, 050209002-005
RECALLING FIRM/MANUFACTURER
Ekos Corp., Bothell, WA, by letters on November 22, 2004 and by visit on March 10, 2005. Firm initiated recall is complete.
REASON
During two separate procedures, the user experienced difficulty placing the EKOS ultrasound core (USC) into the EKOS drug delivery catheter (DDC) when transiting tight bend radii; specifically the aortic bifurcation. In one case, the USC fractured within the DDC when the user attempted to withdraw the USC after resistance was encountered.
VOLUME OF PRODUCT IN COMMERCE
128 kits
DISTRIBUTION
AZ, OH, WA, FL, IL, and CA

______________________________
PRODUCT
a) QUIK-COMBO pacing/defibrillation/ECG (therapy) cables
used with the LIFEPAK 12 defibrillator/monitor series,
part number: 3006570-006 and below, Recall # Z-0116-06;
b) Standard (hard) paddles used with the LIFEPAK 12
defibrillator/monitor series. Part number: 3006228-013
and below, Recall # Z-0117-06
CODE
No serial or lot numbers
RECALLING FIRM/MANUFACTURER
Medtronic Emergency Response Systems, Inc., Redmond, WA, by letters on September 2, 2005. Firm initiated recall is ongoing.
REASON
Potential for voltage pins in connector of therapy cable to break.
VOLUME OF PRODUCT IN COMMERCE
52,654 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile, Recall # Z-0124-06
CODE
Lot number: 051781, 051782, 051783, 051788, 0517939
RECALLING FIRM/MANUFACTURER
Remington Medical Inc., Alpharetta, GA, by sales personnel on August 31, 2005. Firm initiated recall is ongoing.
REASON
The vector selector has an electrical design flaw which prevents RV pacing.
VOLUME OF PRODUCT IN COMMERCE
600 units
DISTRIBUTION
MN

______________________________
PRODUCT
Bari Maxx II, KCI's BariMaxx II bariatric bed, P/N 310611, November 2001, Product Code 80 FNL, Recall # Z-0129-06
CODE
Serial numbers: BKOk00006 through BKOK00100
RECALLING FIRM/MANUFACTURER
Kinetic Concepts, Inc, San Antonio, TX, by letter on August 16, 2005. Firm initiated recall is complete.
REASON
Design change to upgrade reliability of powered adjustable bed.
VOLUME OF PRODUCT IN COMMERCE
93 beds
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Hemosense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21, Recall # Z-0132-06
CODE
Serial Numbers: 044609678, 051613670, 051613713, 052613997, 052614025, 044810630, 051613674, 051613714, 052613998, 052614026, 044810759, 051613675, 051613721, 052613999, 052614027, 045110807, 051613676, 051613722, 052614000, 052614028, 045110825, 051613679, 051613723, 052614002, 052614029, 051613114, 051613681, 051613730, 052614003, 052614030, 051613119, 051613682, 051613733, 052614004, 052614031, 051613121, 051613683, 051613742, 052614006, 052614032, 051613125, 051613685, 051613745, 052614007, 052614033, 051613127, 051613686, 051613746, 052614008, 052614035, 051613154, 051613687, 051613747, 052614010, 052614040, 051613156, 051613689, 051613748, 052614011, 052614042, 051613164, 051613691, 052613972, 052614012, 052614045, 051613174, 051613693, 052613975, 052614013, 052614049, 051613241, 051613695, 052613978, 052614014, 052614050, 051613247, 051613696, 052613979, 052614015, 052614051, 051613256, 051613697, 052613981, 052614016, 052614060, 051613261, 051613701, 052613984, 052614017, 052614063, 051613655, 051613702, 052613986, 052614018, 052614065, 051613656, 051613704, 052613991, 052614019, 052614072, 051613660, 051613705, 052613992, 052614020, 052614078, 051613661, 051613707, 052613993, 052614021, 052614079 051613662, 051613710, 052613994, 052614022, 052614085, 051613663, 051613711, 052613995, 052614023, 051613665, 051613712, 052613996, 052614024
RECALLING FIRM/MANUFACTURER
Hemosense, Inc., San Jose, CA, by letters and telephone on September 7, 2005. Firm initiated recall is ongoing.
REASON
A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition. 7.5' test message under a particular use condition." name=prdReason0
VOLUME OF PRODUCT IN COMMERCE
123 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) LifeShield Latex-Free HEMA Blood PlumSet; Nonvented,
100 inch, with 210 Micron Filter, Prepierced
Injection Site and Option-Lok, Dual Channel
Capped Secondary Port; List 11235-03,
Recall # Z-0133-06;
b) LifeShield Latex-Free HEMA Y-Type Blood PlumSet,
Nonvented, 122 inch, with 210 Micron Filter,
Prepierced Injection Site, Prepierced Secondary
Port and Option-Lok for use with Plum Series Infusers;
list 11664-03, Recall # Z-0134-06;
c) LifeShield Latex-Free HEMA Y-Type Blood PlumSet,
Nonvented, 122 inch, with 210 Micron Filter, Inline
Dual Channel Cassette, 2 Clave Ports and Option-Lok
for use with Plum Series Infusers; list 12259-02,
Recall # Z-0135-06
CODE
a) Lot numbers: 270735H, 271635H;
b) Lot numbers: 240285H, 261265H, 271075H, 280885H;
c) Lot numbers: 220635H, 230555H, 240305H, 240605H,
250875H, 260495H, 270025H, 271085H, 271645H, 280895H
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letters dated September 29, 2005.
Manufacturer: Abbott Laboratories de Costa Rica S.A., La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.
REASON
Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
VOLUME OF PRODUCT IN COMMERCE
627,390 sets
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512, Recall # Z-0136-06
CODE
Kit lots# 63-502081, 63-502081A contain Calibration Verifiers 1, 2, and 3. Lot #30-500952 is specific to Calibration Verifier 2; Lot #30-500953 is specific to Calibration Verifier 3.
RECALLING FIRM/MANUFACTURER
Nichols Institute Diagnostics, San Clement, CA, by fax and letter on September 29, 2005. Firm initiated recall is ongoing.
REASON
Some units in Lot 30-500953 (Calibration Verifier 2) are mislabeled as Calibration Verifier 3. Some units of Lot 30-500953 (Calibration Verifier 3) are mislabeled as Calibration Verifier 2.
VOLUME OF PRODUCT IN COMMERCE
215 units
DISTRIBUTION
CA, IN, and WA

______________________________
PRODUCT
Vitros ECi Immunodiagnostic System, sold as Catalog #863 3893; Catalog #192 2814 (Vitros ECiQ), and Catalog #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units, Recall # Z-0137-06
CODE
All Vitros ECi units currently on the market (software version 3.1 or lower).
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letters dated September 29, 2005. Firm initiated recall is ongoing.
REASON
When using Vitro ECi Immunodiagnostic System with Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs, results of the 1st of two required re-test replicates may be negatively biased.
VOLUME OF PRODUCT IN COMMERCE
3,507 Vitros Eci systems
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735, Recall # Z-0138-06
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on October 3, 2005.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
If the recommended workflow is not followed and the worksheets are printed after moving the patient table out of isocenter, the offset values will be incorrect. This could result in a biopsy being performed at an incorrect location and presents the possibility of an inconclusive diagnosis.
The recalling firm issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions MR034/05/S. The letter re-emphasizes the importance of printing the offset values on the worksheet prior to moving the patient table and in accordance with the User's Manual.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Optimus 30, Recall # Z-1084-06
CODE
Serial numbers: G15733, G15704, G15729, G14262, G15750, G15500, G15726, G14065, G15516, G15622, G14118, G14504, G15525, G15551, G14444, G14445, G14406, G15810, G15855, G16651, G16167, G15861, G15858, G15921, G15974, G16132, G16567, G16678, G17593, G16259, G16146, G16573, G17052, G17556, G17504, G16347, G17520, G17506, G17400, G17773, G17774, G17403, G16393. One unit identified with site #103950
RECALLING FIRM/MANUFACTURER
Philips Ultrasound, Inc., Bothell, WA, by visit on/about February 24, 2004. Firm initiated recall is ongoing.
REASON
Systems do not comply with the labeling performance standards.
VOLUME OF PRODUCT IN COMMERCE
44 devices
DISTRIBUTION
Nationwide

 

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

_______________________________
PRODUCT
Tru-Link DIN unshielded ECG cable, 5-lead, Part number: 012-0123-01, Recall # Z-0063-06
CODE
Lot codes: 31942, 34956, 35209, 35296, 35747, 36239, 36555
RECALLING FIRM/MANUFACTURER
Spacelabs Medical Inc, Issaquah, WA, by letter on September 16, 2005. Firm initiated recall is ongoing.
REASON
ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect.
VOLUME OF PRODUCT IN COMMERCE
632 cables
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Accumetrics VerifyNow Instrument, printe power supply, Part number: 29001, Recall # Z-0102-06
CODE
Lot number: G-13850
RECALLING FIRM/MANUFACTURER
Accumetrics Inc., San Diego, CA, by letters on September 13, 2005. Firm initiated recall is ongoing.
REASON
In 2001, separate reports of mild shock, sparking and smoke from Accumetrics PN 29001 power supply.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
CA, FL, IL, LA, NH, NV, NY, OK, WA

_______________________________
PRODUCT
a) Jet Medical 4F x 60cm Single Lumen Polyurethane PICC
Nursing Tray. Catalog number JDMPN4S-T,
Recall # Z-0103-06;
b) Jet Medical 4F Single Lumen PICC Kit.
Catalog number JP7-4, Recall # Z-0104-06
CODE
a) Lot number: MABY360;
b) Lot number: MABY950
RECALLING FIRM/MANUFACTURER
Medical Components, Inc., dba MedComp, Harleysville, PA, by telephone on September 15, 2005. Firm initiated recall is ongoing.
REASON
The product is labeled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray.
VOLUME OF PRODUCT IN COMMERCE
98 units
DISTRIBUTION
OH and MO

_______________________________
PRODUCT
a) Arcadis Varic Mobile X-Ray System. Model number 8080017,
Recall # 0118-06;
b) Arcadi Orbic Mobile X-Ray System. Model number 8081080,
Recall # Z-0119-06;
c) Siremobil Compact Mobile X-Ray System. Model number
3776494, Recall # 0120-06;
d) Siremobil Compact L Mobile X-Ray System. Model number
3780629, Recall # 0121-06;
e) Siremobil Iso-C Mobile X-Ray System. Model number
2829450, Recall # 0122-06;
f) Powermobil Mobile X-Ray System, Model number 2830011,
Recall # Z-0123-06
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by visit beginning on August 11, 2005. Firm initiated recall is ongoing.
REASON
Screws may become loose and fall into the OR field during surgery.
VOLUME OF PRODUCT IN COMMERCE
167 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Tosoh brand Glycohemoglobin Alc Controls I & II, Catalog Number: 992133, Recall # Z-0131-06
CODE
Kit Lot Number: 31205; Controls I & II Lot Numbers: 31009AA, 31010AA
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tosoh Bioscience, Inc., South, San Francisco, CA, by letter on August 18, 2005.
Manufacturer: Aalto Scientific, Ltd., Carlsbad, CA. Firm initiated recall is ongoing.
REASON
The firm has received reports that vials of the Level II were exhibiting poor and inconsistent chromatogram quality thus affecting control results.
VOLUME OF PRODUCT IN COMMERCE
3,284 boxes
DISTRIBUTION
Nationwide, Canada, Puerto Rico, Chile and Brazil


END OF ENFORCEMENT REPORT FOR NOVEMBER 16, 2005

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