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U.S. Department of Health and Human Services

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Enforcement Report for August 23, 2006

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.

August 23, 2006
06-34

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
ZOMIG (Zolmitriptan), 2.5 mg Tablets, Rx only, NDC 0310-0210-20, Recall # D-330-6
CODE
Lot # 103158 Exp. Date: 09/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: AstraZeneca Pharmaceutical LP, Wilmington, DE, by letter on July 24, 2006.
Manufacturer: IPR Pharmaceutical, Inc., Carolina, PR. Firm initiated recall is ongoing.
REASON
Some blister cells may not contain product.
VOLUME OF PRODUCT IN COMMERCE
42,192 blister packs
DISTRIBUTION
Nationwide

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PRODUCT
GABAPENTIN *** Capsules *** 300 mg *** Rx Only *** 2000 Capsules (Yellow/White) *** IVAX Pharmaceuticals, Inc. ****** NDC 0172-4382-88 ***, Recall # D-331-6
CODE
Lot # 139631C, Expiration Date April 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami, FL, by letters on June 20, 2006.
Manufacturer: Ivax Pharmaceuticals, Inc., Cidra, PR. Firm initiated recall is ongoing.
REASON
The Active Pharmaceutical Ingredient (API) does not meet specifications.
VOLUME OF PRODUCT IN COMMERCE
1,373/2000 count bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0537-6
CODE
Unit: 027LR64386
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on November 8, 2005, and by letter dated November 9, 2005. Firm initiated recall is complete.
REASON
Red Cells, with an unacceptable volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1456-6
CODE
Unit: 22LC26946
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone and letter on February 21, 2006. 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
PA

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PRODUCT
a) Red Blood Cells, Recall # B-1488-6;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1489-6;
c) Recovered Plasma, Recall # B-1490-6;
CODE
a) Units: 03LL14732, 03FV60345;
b) Unit: 03GF59615;
c) Units: 03LL14732, 03GF59615
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by letter dated September 5, 2000 and by facsimile dated September 11, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information relating to positive test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
GA

______________________________
PRODUCT
Capture-S Indicator Red Cells, Recall # B-1598-6
CODE
Lot 28477R
RECALLING FIRM/MANUFACTURER
Immucor, Inc., Norcross, GA, by letter dated August 24, 2005. Firm initiated recall is ongoing.
REASON
One lot of Indicator Red Cells showing weak or negative reactivity when tested with Capture-S Reactive Control Serum, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Lot
DISTRIBUTION
Nationwide, Italy, Germany and Portugal

______________________________
PRODUCT
Recovered Plasma, Recall # B-1633-6
CODE
Unit: 9084156
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva Inc., Newark, DE, by fax on March 15, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt - Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1640-6
CODE
Unit: 027GL78845
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on February 22, 2006 and follow-up letter dated February 23, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WV

______________________________
PRODUCT
Red Blood Cells, Recall # B-1641-6
CODE
Unit: 1028731
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on March 13, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1642-6;
b) Fresh Frozen Plasma, Recall # B-1643-6
CODE
a) and b) Unit: 8026713
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE, by telephone on February 1, 2006 and follow-up letter dated March 6, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received rabies vaccine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
DE

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1644-6;
CODE
Units: 22LE10597 (split product)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Philadelphia, PA, by telephone on October 6, 2005 and letter dated October 18, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire was not completed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA

______________________________
PRODUCT
Galileo Automated Blood Bank Analyzer (in-vitro diagnosis testing of human blood using a microplate platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red cell antibodies and compatibility testing), Recall #B-1645-6
CODE
Catalog Numbers: 0064997; 0064999
RECALLING FIRM/MANUFACTURER
Immucor, Inc., Norcross, GA, by telephone beginning March 30, 2006 and by letter dated March 30, 2006. Firm initiated recall is ongoing.
REASON
Blood Bank Analyzer, with a software glitch, was distributed.
VOLUME OF PRODUCT IN COMMERCE
121 units
DISTRIBUTION
Nationwide, Canada and Japan

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1695-5;
b) Platelets, Recall, Recall # B-1696-6
CODE
a) and b) Unit: 3103801
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter dated January 20, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1700-6
CODE
Unit 30GP43761
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on March 30, 2006 and by follow-up letter dated March 31, 2006. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1703-6
CODE
Unit: 71X400916
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by letter dated March 4, 2006. Firm initiated recall is complete.
REASON
Blood product, which yielded a platelet count that was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1704-6
CODE
Unit: 1149556
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University, Cincinnati, OH, by letter dated September 13, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

______________________________
PRODUCT
Red Blood Cells, Recall # B-1705-6
CODE
Unit: 0988754
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by letter dated February 8, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1307-6
CODE
Units: 10746-4393 (split unit), 10746-4361, 10746-5304
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on January 27, 2003. Firm initiated recall is complete.
REASON
Blood products, out of controlled storage for an undocumented length of time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AZ

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1649-6
CODE
Unit: LE97158
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on February 21, 2005. Firm initiated recall is complete.
REASON
Blood product, for which the documentation of weld acceptability for the sterile docking of the filter was incorrect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use only; Ref/Catalog No. 820-100, UPN Product No. (M0068201000), Recall # Z-1309-06
CODE
Lots 8555778, 8552615 and 8718072
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Spencer, IN, by letters dated June 2, 2006. Firm initiated recall is ongoing.
REASON
The packages are labeled sterile, but the product was not sterilized.
VOLUME OF PRODUCT IN COMMERCE
27
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Edwards Vigilance Monitors (Formerly Baxter Vigilance Monitors). Patient monitor which measures cardiac output. Models: VG, VGS, VGS1, VGS2, VG2, & IVM, Recall # Z-1310-06
CODE
All devices serialized with software release 5.3 or earlier.
RECALLING FIRM/MANUFACTURER
Edwards Lifesciences Llc, Irvine, CA, by telephone and letter dated July 7, 2006. Firm initiated recall is ongoing.
REASON
Edwards Lifesciences Vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the Continuous Cardiac Output (CCO) catheter without alerting the user to this situation. This can result in overheating and thermal damage to the CCO catheter and serious patient injury.
VOLUME OF PRODUCT IN COMMERCE
8,305 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717, 747, 902, 911, 912, 917, Modular and cobas c 501 clinical chemistry analyzers. Roche Catalog/Part Number 10825441001/US # 722-4402, Recall # Z-1352-06.
CODE
Lots L33 through L50 through L99 and all M series lots.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated July 14, 2006.
Manufacturer: Division, Hitachi Ltd., Hitachinaka-Ibaraki, Japan. Firm initiated recall is ongoing.
REASON
A design change in the electrodes will result in incorrect potassium level results.
VOLUME OF PRODUCT IN COMMERCE
1,970 electrodes
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with Multi Planar Reformat (MPR) Option, Recall # Z-1353-06
CODE
PACS EasyVision / EasyAccess Release 10.1/10.2 Site numbers 542691, 105592, 519705, 100640, 541132, 530547, 76937, 105094, 505455, 85176, 105803, 105806, 505284, 13928, 105176, 505609, 536655, 86261, 105090, 101590, 105419, 84402, 505625, 104599, 505829, 532250, 105105, 103767, 532248, 541162, 85052, 532200, 20920024, 105257, 532654, 532642, 533323, 86050, 506259, 533223, 538795, 105106, 505267, 104946, 538798, 84026, 84033, 83937, 538801, 103513, 105374, 506328, 536253, 542386, 533622, 538484, 104551, 103066, 537982, 505674, 530752, 506046, 85173, 100592, 505623, 101168, 506700, 506367, 532390, 519811, 541133, 540768, 84083, 101378, 104982, 103096, 506265, 530448, 536658, 521136, 535317, 506000, 105026, 105067, 105043, 506505, 84896, 84873, 532946, 506461, 539156, 105604, 506122, 505973, 533999, 532691, 531852, 534508, 505388, 102155, 521761, 519977, 540771, 533268, 505001, 505183, 86345, 45053, 530661, 105021, 101356, 103220, 520416, 102594, 505065, 520458, 103340, 105931, 532583, 521516, 105765, 505796, 542077, 520442, 506228, 530805, 105599, 86457, 530553, 103715, 504825, 534766, 521200, 540249, 506001, 105517, 530555, 84967, 505897, 505898, 86198, 506161, 506226, 538802, 533720, 84866, 101033, 10381, 505427, 101419, 530518, 519965, 532368, 506707, 102076, 505044, 519629.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co., Phillips, Bothell, WA, by letter on July 1, 2006.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
Potential for measurements, lines, texts, etc to be stored incorrectly. Any added arrow will point to the wrong anatomical structure and this will make the image useless in combination with reported findings.
VOLUME OF PRODUCT IN COMMERCE
157 devices
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) ACCU-CHEK Advantage Blood Glucose Meter/ Blood Glucose
Monitoring System; Cat. no. 870. Ref. no. 080087000 with meter
model number 870; Ref. no.0353756001 with meter model number
33304510; Ref. no. 03537536001 with meter model no. 2138930;
Ref. no. 03537536001 with meter model no. 3288650, Recall # Z-1354-06;
b) ACCU-CHEK Advantage Complete Diabetes Monitoring Kit,
Cat. No. 860. Ref. no. 080086000 with meter model number 870;
Ref. no. 03002531001 with meter model number 33304510;
Ref. no. 03002531001 with meter model number 2138930;
Ref. no. 03002531001 with meter model number 2138930,
Recall # Z-1355-06;
c) ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 2137500;
Ref. no. 0385633001 with meter model no. 768, Recall # Z-1356-06;
d) ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 3332586;
Ref. no. 03332586001 with meter model no. 2138930, Recall # Z-1357-06;
e) ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001
and 12139642001 both with meter model number 2138930, Recall # Z-1358-06;
f) ACCU-CHEK Comfort Curve. Cat. No. 3149030; Ref. number 0314903001
with meter model number 2138930, Recall # Z-1359-06;
g) ACCU-CHEK Advantage (Managed Care Kit) 100- value memory
with time and date, Not for Retail Sale, Cat. No. 3000389; Ref no.
03000389001 with meter model no. 2138930, Recall # Z-1360-06;
h) ACCU-CHEK Advantage (Conversion Kit),Cat. no. 3000338;
Ref no. 03000338001 with meter model no. 2138930, Recall # Z-1361-06;
i) ACCU-CHEK Advantage (Consignment kit), Cat. no. 3000320; catalog
no. 03000320001 with meter model no. 2138930, Recall # Z-1362-06;
j) ACCU-CHEK Complete diabetes monitoring kit/ care kit/ insulin pump
therapy kit, Cat. no 515; Ref. nos. 03144852001 and 12031981001
with meter model no. 200 and Ref. no. 03144852001 with meter
model no. 250, Recall # Z-1363-06;
k) ACCU-CHEK Complete blood glucose monitor, Ref. no. 516;
Catalog nos. 03266770001 and 03871983001 with meter model
no. 200 and Catalog no. 03871983001 with meter model number
250, Recall # Z-1364-06;
l) ACCU-CHEK HQ for Blood Glucose Monitoring and Automated
Data Management and Communication; Contents include two
Accu-Chek Advantage monitors including Cat. no. 2138018 and
Cat. no. 2138026. Ref. nos. 12138018001 and 12218542001 both
include meters with model number 777, Recall # Z-1365-06;
m) AccuData GTS Plus for Blood Glucose Monitoring and Automated
Data Management including GTS Plus with Accu-Chek Advantage
blood glucose meter, Cat no. 3000249 and/or GTS with Accu-Chek
Advantage blood glucose meter, Cat. no. 404, and/or Replacement
GTS with Accu-Chek Advantage blood glucose meter, Cat. no. 404R,
and/or Replacement Base Unit with Advantage Module, Cat. no.
3426050. Ref. nos. 030002490001 and 03136833001 both have meters
with model no. 777, Recall # Z-1366-06;
n) AccuData GTS Plus AccuData GTS For Blood Glucose Monitoring
and Automated Data Management, contents Accu-Chek Advantage
replacement Meter and module, cat. no. 454; Ref. no. 03144798001
contains meter model no. 777, Recall # Z-1367-06;
o) GTS Advantage Meter. Cat. no. 424. Ref. no. 03144780001 with meter
model no. 777, Recall # Z-1368-06;
p) ACCU-CHEK Advantage FPO Diabetes Monitoring Kit, Cat. no.
3271358001. Ref. no. 03271358001 with meter model no. 3288650,
Recall # Z-1369-06;
q) ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and
Voice Unit - English language version for the blind or visually impaired,
Cat. no 2030802. Ref. no. 12030802001 with meter model no. 768,
Recall # Z-1370-06;
r) ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter
and Voice Unit - Spanish language version for the blind or visually
impaired, Cat. no. 3040208. Ref. no. 03040208001 with meter model no.
768, Recall # Z-1371-06
CODE
All units.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated June 22, 2006.
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany. Firm initiated recall is ongoing.
REASON
The meter gives an error message that can actually mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that the test strip may be damaged or test was not performed correctly.
VOLUME OF PRODUCT IN COMMERCE
55,189 meters
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Roche MagNA Pure LC System (RMD); Catalog no. 03670325001.
An automated, general purpose instrument for isolation and purification of
nucleic acids and assembly of PCR reactions. Recall # Z-1372-06;
b) Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. .
An automated, general purpose instrument for isolation and purification of
nucleic acids and assembly of PCR reactions. Recall # Z-1373-06;
c) Roche MagNA Pure LC Instrument; Catalog nos. 12236931692 (Refurbished)
and 12236931690 (Return). An automated, general purpose instrument for
isolation and purification of nucleic acids and assembly of PCR reactions.
Recall # Z-1374-06;
CODE
All units.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated July 17, 2006.
Manufacturer: Precision System Science Co., Ltd., Chiba, Japan. Firm initiated recall is ongoing.
REASON
If the user opens the instrument lid during decontamination, the cycle will stop, but the timer will continue resulting in the user believing the instrument has been decontaminated when it has not.
VOLUME OF PRODUCT IN COMMERCE
771 instruments
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators, Recall # Z-1375-06.
CODE
H462074, H462000, H462003, H462004, H462005, H462006, H462011, H462012, H462013, H462014, H462015, H462016, H462017, H462018, H462019, H462020, H462021, H462022, H462023, H462024, H462025, H462026, H462027, H462028, H462029, H462031, H462040, H462045, H462047, H462048, H462049, H462050, H462051, H462052, H462054, H462055, H462057, H462059, H462060, H462061, H462064, H462065, H462066, H462067, H462068, H462072, H462073, H462075, H462076, H462077, H462079, H462082, H462083, H462084, H462085, H462086, H462087
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on September 20, 2005. Firm initiated recall is ongoing.
REASON
A software anomaly may occur which can lead to patient treatment with the wrong field. The anomaly is reported only to occur when this software version (6.6.5022) is used with Elekta or Siemens linear accelerators.
VOLUME OF PRODUCT IN COMMERCE
58 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Accu-Chek Comfort Curve blood glucose test strips; (packaged in 10s, 50s,
and/or 100s) U.S. Reference nos. 12030420001, 12030373001, 12030381001,
12030365001, 04388208001, 04388186001 and 03000141001,
Recall # Z-1377-06;
b) Accu-Chek Advantage blood glucose test strips; U.S. Reference nos.
(packaged in 50s and/or 100s) 03144917001, 03144704001, 03145263001
and International Reference nos. 12030551001, 12030578001 and 12030586001,
Recall # Z-1378-06;
c) Accu-Chek Advantage II blood glucose test strips; International Reference nos.
12030659001, 12030667001, 03137872001, 03137899001, 03000281001,
12030535001, 12030543001, 03033449001, 03033465001 and 12030543047,
Recall # Z-1379-06;
d) Accu-Chek Sensor Comfort blood glucose test strips; International Reference nos.
03261956170, 03261964170, 03146154192, 03146146192, 03374700023,
03374718023, 11895133192, 11895141192, 03522091016, 03051161003,
03051170003, 03322033122, 03322041122 and 03587304122, Recall # Z-1380-06;
e) Accu-Chek Sensor Comfort Pro blood glucose test strips; International Reference
nos. 03758770001, 03360652080, 03051188003, 03620115003, and 04535235003,
Recall # Z-1381-06;
f) Accu-Chek Advantage Plus blood glucose test strips; International Reference no.
04735102001, Recall # Z-1382-06;
g) Accu-Chek Advantage Pro blood glucose test strips; International Reference no.
04534972001, Recall # Z-1383-06;
h) Accu-Chek Inform blood glucose test strips; International Reference nos.
04535057001, 04647696001 and 04535120001, Recall # Z-1384-06
CODE
All lots expiring before July 31, 2007.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter dated June 28, 2006. Firm initiated recall is ongoing.
REASON
The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results.
VOLUME OF PRODUCT IN COMMERCE
66,000,000 vials
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216), Recall # Z-1385-06
CODE
Lot 674653, Exp. 12/31/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated July 25, 2006.
Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.
REASON
The vial containing the R2 reagent is labeled as R1 reagent and if placed in the R1 slot of the analyzer, erroneous results will be obtained. (extremely low patient and control results).
VOLUME OF PRODUCT IN COMMERCE
20 kits
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series,
manufactured from 8/1998 through 11/2004, Recall # Z-1386-06;
b) Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-800 Series,
manufactured from 8/2004 through 9/2005, Recall # Z-1387-06
CODE
All analyzers manufactured from 8/1998-11/2004, are subject to recall. The devices contain serial numbers 902-441RxxxNxxx. The Rxxx number denotes manufacturing run, and the Nxxx number denotes the individual instrument within the run.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., WestlakeOH, by letter dated September 29, 2005.
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON
Under certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low) result values for Calcium (Ca) and Sodium (Na).
VOLUME OF PRODUCT IN COMMERCE
1,811 devices
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Liquid Alkaline Phosphatase Reagent Set for the quantitative determination of
alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.;
Catalog nos. A7516-150, A7516-450, A7516-625, HA716-246, HA716-2400,
HA916-302 and HA916-492. In vitro diagnostic, Recall # Z-1388-06;
b) Liquid Alkaline Phosphatase (R1) Reagent Set for the quantitative determination
of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.;
Catalog no. H A416-R1. In vitro diagnostic; Recall # Z-1389-06;
c) Liquid Alkaline Phosphatase (R2) Reagent Set for the quantitative determination
of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.;
Catalog no. H A416-R2. In vitro diagnostic, Recall # Z-1390-06;
d) Alkaline Phosphatase Buffer Mfg. for Alfa Wassermann Diagnostic
Technologies LLC, Caldwell, N.J. in 8.4 mL and 30 mL containers. In vitro
diagnostic, Recall # Z-1391-06;
e) Alkaline Phosphatase Substrate Mfg. for Alfa Wassermann Diagnostic
Technologies LLC, Caldwell, N.J. in 2.1 mL and 7.5mL containers. In vitro
diagnostic, Recall # Z-1392-06;
f) Liquid Alk Phos Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-L.
In vitro diagnostic, Recall # Z-1393-06;
g) Liquid Alk Phos R1 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R1.
In vitro diagnostic, Recall # Z-1394-06;
h) Liquid Alk Phos R2 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R2.
In vitro diagnostic, Recall # Z-1395-06;
i) Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent in 50 ml,
120 ml, 2 L and 500 ml containers, sold by Pointe Scientific; Catalog nos.
7-HA716-R1-50-917, 7-A7516-R1-120, 7-A7516-R1-2L, 7-A7516-R1-500,
7-HA716-R1-500, 8-A7516-R1-120 and 8-A7516-R1-500. In vitro diagnostic,
Recall # Z-1396-06;
j) Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent in 30 ml,
90 ml, 125 ml and 400 ml containers, sold by Pointe Scientific; Catalog nos.
7-A7516-R2-125, 7-A7516-R2-30, 7-A7516-R2-400ML, 7-A7516-R2-90,
8-A716-R2-125, 8-A7516-R2-30 and 8-A7516-R2-90. In vitro diagnostic,
Recall # Z-1397-06
CODE
a) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07),
530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07);
b) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07),
530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07);
c) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07),
530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07);
d) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07),
530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07);
e) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07),
530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07);
f) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07),
530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07);
g) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07),
530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07);
h) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06),
521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and
607601 (exp. 9/07);
i) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07),
530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07).
j) Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07),
530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07)
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Lincoln Park, MI, by letter dated June 9, 2006. Firm initiated recall is ongoing.
REASON
The reagent may be contaminated with microorganisms.
VOLUME OF PRODUCT IN COMMERCE
890 L total
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst
and vers.-row, part number GM11005400, for the GammaMed model 12i
radionuclide applicator system, Recall # Z-1398-06;
b) GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst
and vers.-row , part number GM11005400, for the GammaMed model 12it
radionuclide applicator system, Recall # Z-1399-06
CODE
a) GammaMed ''12i'' serial numbers: GM00797 GM00795 GM00896 GM00852
GM00873 GM00708 GM0F278 GM00710 GM00848 GM00899 GM00820
GM00757 GM00821 GM00889 GM00727 GM00706 GM0710 GM00898
GM00743 GM00826 GM00784 GM00786;
b) GammaMed ''12it'' serial numbers: GM00213 GM00218 GM00219TB GM00215
GM00202 GM00216 GM00217 GM00212 GM00219TA GM00219 GM00210
GM00214 GM0213
RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems, CharlottesvilleVA, by letter on 4/17/06 and continuing through 5/1/06.
Manufacturer: Varian Medical Systems, Haan, Germany. Firm initiated recall is ongoing.
REASON
Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients. There is a hazard when entering the treatment plans manually that the user neglects to change the default step size and/or the origin or accidentally enters incorrect parameters.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface, Recall # Z-1401-06
CODE
Site Numbers 93-0452, 93-0494, 93-0571, 93-0724, 93-0881, 93-0894, 93-0902, 93-0443, 93-0776, 93-0677, 93-1032, 93-0880, 93-0010, 93-0095, 93-0432, 93-0991, 93-0711, 93-0007, 93-0641, 93-0356, 93-0391, 93-0015, 93-0118
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc, ConcordCA, by letter on June 22, 2006.
Manufacturer: Impac Medical Systems Inc, Mountain View,CA. Firm initiated recall is ongoing.
REASON
Improper treatment may be delivered if the machine configuration file is edited/set for the Varian MLC revision H file format.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
a) Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode
Part Number: 945-603, distributed one (1) electrode per box, Recall # Z-1323-06;
b) Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode
Part Numbers: 945-633, distributed one (1) electrode per box, Recall # Z-1324-06
CODE
a) Lot #96-01 and #96-02;
b) Lot #96-02 and Lot #96-03
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., WestlakeOH, by E-Mail on September 19, 2005, and by telephone on or around September 20, 2005.
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON
Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument.
VOLUME OF PRODUCT IN COMMERCE
43 Electrodes
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
ABX Pentra 120, 120R, 120DX, automated hematology analyzer, Recall # Z-1334-06
CODE
All serial numbers, all software versions.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ABX Diagnostics, Inc., Irvine, CA, by letter and telephone on March 24, 2006.
Manufacturer: Horiba ABX, Montpellier, France. Firm initiated recall is ongoing.
REASON
Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.
VOLUME OF PRODUCT IN COMMERCE
86 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Pronto M51 Wheelchair, component-seat, Recall # Z-1400-06
CODE
No code
RECALLING FIRM/MANUFACTURER
Recalling Firm: Invacare Corp., Elyria, OH, by letter dated June, 2006.
Manufacturer: Viscount Vehicle Co. LTD, Taiwan, Republic of China. Firm initiated recall is ongoing.
REASON
Some of the wheelchairs were distributed with seats that did not have a seat positioning strap.
VOLUME OF PRODUCT IN COMMERCE
560 seats
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS I

______________________________
PRODUCT
WSI Pride Mature Horse feed pellets in 50 lb. paper bags, Recall # V-083-6
CODE
Lot No. 7701-050306
RECALLING FIRM/MANUFACTURER
Western Stockmen, Caldwell, ID, by telephone on June 14, 2006 and by press release on June 22, 2006. Montana State initiated recall is complete.
REASON
Product contains Rumensin which is toxic to horses.
VOLUME OF PRODUCT IN COMMERCE
70/50 lb. bags
DISTRIBUTION
ID, MT and OR


END OF ENFORCEMENT REPORT FOR AUGUST 23, 2006

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