FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and
Drug Administration,
U.S. Public Health Service, Department of Health and Human
Services. It contains information
on actions taken in connection with agency regulatory
activities.
December 29, 1999 99-52
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________
PRODUCT
Nova Salmon Bits, in 8 ounce plastic tubs...Recall #F-072-0.
CODE
SELL BY 1030 and batch code of 239 on a separate label on the
bottom of the container.
MANUFACTURER
Blue Ribbon Smoked Fish Company, Brooklyn, New York.
RECALLED BY
Manufacturer, by letter and press release on October 1, 1999.
Completed recall resulted from sample analysis and follow-up by
the New York State Department of Agriculture and Markets.
DISTRIBUTION
New York and New Jersey.
QUANTITY
75 8-ounce units were distributed.
REASON
Product was contaminated with Listeria monocytogenes.
________
PRODUCT
Kendall Brook Smoked Atlantic Salmon with Added Cracked Pepper &
Garlic, in 8 ounce plastic bags.
Recall #F-078-0.
CODE
942022.
MANUFACTURER
Ducktrap River Fish Farm, Inc., Belfast, Maine.
RECALLED BY
Manufacturer, by telephone on November 18, 1999, followed by
letter and press release on November 19, 1999. New York issued a
press release on November 17, 1999 in New York. Completed recall
resulted from sample analysis and follow-up by the New York State
Department of Agriculture and Markets.
DISTRIBUTION
Connecticut, Maryland, Pennsylvania, Massachusetts, New York.
QUANTITY
18.50 pounds were distributed.
REASON
Product was contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________
PRODUCT
Swanson Great Starts French Toast Sticks, 4.25 ounces (120
grams). Recall #F-074-0.
CODE
On individual carton & cases:
Product Code (Bar Code): "0 51000 10026"
On Case: On individual Carton:
Production code: "3805110D31A" B, C, D, E, F, G, H Production code: "NOV0008059"
Production code: "3805110D35J" K, L, M, N, O, P, R Production code: "NOV0008059"
Production code: "3812110D55J" K, L, M, N, O Production code: "NOV0008129"
Production code: "3817110D31A" B, C, D, E, F, G Production code: "NOV0008179"
Production code: "3817110D35J" K, L, M, N, O Production code: "NOV0008179"
Production code: "3820110D35L" M, N, O, P, R Production code: "NOV0008209"
Production code: "3824120D35J" K, L, M, N, O, P, R Production code: "DEC0009249".
MANUFACTURER
Rich-SeaPak Corporation, Brunswick, Georgia.
RECALLED BY
Vlasic Food International, Cherry Hill, New Jersey, by letter on
November 1, 1999, by E-mail or fax. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
21,287 cases were distributed; firm estimated that 6,921 cases
remained on market at time of recall initiation.
REASON
Product contains undeclared dairy ingredients.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________
PRODUCT
Drink products in 12 ounce cans, 24 cans per case:
a) Fruitopia Strawberry Passion Awareness; b) Cool from Nestea,
in 12 ounce cans. Recall #F-070/071-0.
CODE
a) FEB2800VJD
b) MAY2900VJC, MAY0100VJD, APR0300VJD, MAR1300VJC, FEB2100VJE
MANUFACTURER
Coca Cola Bottling Company of Oregon, Wilsonville, Oregon.
RECALLED BY
Manufacturer, verbally and by E-mail on October 15, 1999. Firm-
initiated recall complete.
DISTRIBUTION
Washington state, Oregon, California, Hawaii, Montana, Nevada.
QUANTITY
Approximately 288,771 cases of Cool and 687 cases of Fruitopia
were sold.
REASON
Products may be contaminated with yeast and mold.
________
PRODUCT
Powerade Mountain Blast, in 20 ounce containers.
Recall #F-073-0.
CODE
Date Code 9266MD.
MANUFACTURER
The Minute Maid Company for Coca-Cola USA at Coca-Cola Bottling
Company of Chicago, Niles, Illinois.
RECALLED BY
Coca-Cola USA Operations, Atlanta, Georgia, by E-mail and fax on
December 9, 1999. Firm-initiated recall ongoing
DISTRIBUTION
Indiana and Minnesota.
QUANTITY
2,478 cases (24 cans per case) were distributed. Firm estimated
that 620 cases remained on market at time of recall initiation.
REASON
Product is contaminated with mold.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________
PRODUCT
Forest Levothroid Tablets (levothyroxine sodium tablets, USP),
Rx, indicated as replacement or substitution therapy for
diminished or absent thyroid function:
a) LevothroidÆ Tablets (Levothyroxine Sodium), 75 mcg, 100 count.
NDC #0456-0322-01
b) LevothroidÆ Tablets (Levothyroxine Sodium), 100 mcg, 100
count. NDC #0456-0323-01
c) LevothroidÆ Tablets (Levothyroxine Sodium), 125 mcg, 100
count. NDC #0456-0324-01
d) LevothroidÆ Tablets (Levothyroxine Sodium), 137 mcg, 100
count. NDC #0456-0331-01
e) LevothroidÆ Tablets (Levothyroxine Sodium), 150 mcg, 100
count. NDC #0456-0325-01
f) LevothroidÆ Tablets (Levothyroxine Sodium), 175 mcg, 100
count. NDC #0456-0326-01
g) LevothroidÆ Tablets (Levothyroxine Sodium), 200 mcg, 100
count. NDC #0456-0327-01. Recall #D-146/152-0.
CODE
Lot Numbers: a) 10984, 10985, 11981, and 11982 EXP 11/00
b) 19914, 19912, and 19913 EXP 01/01
c) 109810 EXP 10/00, 19917 EXP 01/01, 1991 EXP 07/00,
19919 EXP 01.01, and 19918 EXP 01/01
d) 109811 EXP 10/00, and 2994 02/01
e) 119842 EXP 12/00 and 19926 EXP 01/01
f) 109813 EXP 12/00 and 119844 12/00
g) 99813 EXP 10/00.
MANUFACTURER
Forest Pharmaceuticals, Inc., Cincinnati, Ohio.
RECALLED BY
Forest Pharmaceuticals, Inc., subsidiary of Forest Laboratories,
Inc., St. Louis, Missouri, by letter on November 3, 1999. Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
251,347 100-count bottles were distributed.
REASON
Subpotent.
________
PRODUCT
Ethex Disopyramide Phosphate Extended-Release Capsules, USP, 150
mg, in 100 capsule bottles, Rx for the treatment of documented
ventricular arrhythmias.
NDC #58177-002-04 Recall #D-153-0.
CODE
Lot #L14596 EXP 3/29/02.
MANUFACTURER
KV Pharmaceutical Company, Maryland Heights, Missouri.
RECALLED BY
Ethex Corporation, St. Louis, Missouri, by letter dated November
9, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
6,338 100-capsule bottles were distributed.
REASON
Dissolution failure (6 month stability-12th hour).
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________
PRODUCT
Fluocinolone Acetonide Topical Solution, USP, 0.01%, in 20 and 60
mL bottles, Rx non-sterile, topical solution used to treat
corticosteroid-responsive dermatoses.
Recall #D-140-0.
CODE
All lot numbers within Expiration date.
MANUFACTURER
Bausch and Lomb Pharmaceuticals, Inc., Tampa, Florida.
RECALLED BY
Manufacturer, by letter on November 5, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
219,079 units were distributed; firm estimated that 37,000 units
remained on market at time of recall initiation.
REASON
Subpotency.
________
PRODUCT
DepoCyt(tm) (Cytarabine liposome injection), 50 mg/mL (10 mg/mL),
in 5 mL sterile, single use vial, Rx cytotoxic anticancer drug.
NDC #53905-331-01. Recall #D-143-0.
CODE
Lot #99-0004 and 99-0004A,
MANUFACTURER
SkyePharm, Inc., San Diego, California.
RECALLED BY
Chiron Corporation, Emeryville, California, by letter fax and
telephone beginning October 5, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
569 vials were distributed.
REASON
Product failed % free cytarabine specification (6 month
stability).
________
PRODUCT
HemoridÆ Hemorrhoidal Suppositories, (Zinc Oxide
11%/Phenylephrine Hydrochloride 0.25%), in boxes of 12.
Recall #D-145-0.
CODE
All unexpired lots.
MANUFACTURER
G&W Laboratories, Inc., South Plainfield, New Jersey.
RECALLED BY
Consumer Health Care Group, Parsippany, New Jersey (own label
distributor), by letter on or about October 29, 1998. Firm-
initiated recall complete.
DISTRIBUTION
Nationwide and Puerto Rico.
QUANTITY
1,227,948 units were distributed; firm estimates none remains on
the market.
REASON
Subpotency of phenylephrine (stability testing).
________
PRODUCT
Trilisate Tablets (Choline Magnesium Trisalicylate), 750 mg, 500
count bottles, Rx non-sterodial anti-inflammatory, analgesic and
anti-pyretic preparation. NDC #0034-0505-50. Recall #D-154-0.
CODE
LOT #71G1 EXP 3/01.
MANUFACTURER
The P.F. Laboratories Totowa, New Jersey. (responsible firm).
RECALLED BY
The Purdue Frederick Company, Inc., Norwalk, Connecticut, by
telephone between April 30, 1999, and May 7, 1999, and by letter
during the week of May 3, 1999. Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
792 bottles were distributed. Firm estimated that 359 bottles
remained on market at time of recall initiation.
REASON
Subpotent (choline content).
________
PRODUCT
LevsinÆ Injection (hyoscyamine sulfate), 0.5mg per mL, 1 mL
ampuls, Rx intended for use for gastrointestinal disorders,
diagnostic procedures, and anesthesia. NDC #0091-1536-05.
Recall #D-155-0.
CODE
Lot Numbers: 35281 and 35282 EXP 9/00.
MANUFACTURER
Taylor Pharmaceuticals, Decatur, Illinois.
RECALLED BY
Schwarz Pharma Mfg, Inc., Seymour, Indiana, by letter on October
28, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Republica Dominicana.
QUANTITY
9,296 cartons (5 ampules per box) were distributed.
REASON
Subpotent (18 month stability testing).
________
PRODUCT
Medi-First Extra Strength Non-Aspirin Acetaminophen 500 mg, OTC
pain reliever, packaged in 2 tablet unit dose packets.
NDC #47682-804-99. Recall #D-156-0.
CODE
Lot #2091 EXP 7/03.
MANUFACTURER
Future Pak Ltd., Farmington Hills, Michigan (packet packager).
RECALLED BY
Textilease Medique, Inc. (TMI), Skokie, Illinois (repacker), by
telephone and by letter dated November 18, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Colorado, California, Texas, Missouri, Arkansas, Wisconsin,
Alabama, Michigan, Indiana, Tennessee, Florida, Georgia, South
Carolina, Illinois.
QUANTITY
448 cartons were distributed; firm estimated that 25 percent of
product remained on market at time of recall initiation.
REASON
Mislabeling - Exterior holding/dispensing cartons labeled as non-
aspirin ibuprofen 200 mg.
________
PRODUCT
e-LUDESô Capsules (kava kava, guarana, grape seed, uva ursi, corn
silk, cascara segrada), OTC in 12 count packages. Recall #D-157-
0.
CODE
All lots.
MANUFACTURER
Spectrum Distribution & Marketing, Inc., Beverly Hills,
California (own label distributor/responsible firm).
RECALLED BY
Distributor, by telephone and fax beginning November 15, 1999,
followed by letter dated November 18, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Undetermined
QUANTITY
Approximately 288 units were distributed.
REASON
Product was marketed without an approved new drug application.
________
PRODUCT
Tinactin Antifungal Powder (tolnaftate 1%), in 45, 90, and 108
gram shaker bottles, OTC topically applied antifungal powder.
Recall #D-158-0.
CODE
45 Gram: 8E15AAG, 8E16AG, 8E17AG, 8E18AG, 8H16AAG,
8H17AG, 8K24AAG, 8M03AG, 8N12AG
90 Gram: 8E10AG, 8E11AG, 8E13AG, 8E14AG, 8E15AG, 8E12AG
8E18AAG, 8G01AG, 8G01AAG, 8H13AG, 8H14AG,
8H15AG, 8H16AG
100 Gram: 9A06AG, 9A07AG, 9A08AG.
MANUFACTURER
Ash Corporation, Gulfport, Mississippi.
RECALLED BY
Schering-Plough HealthCare, Memphis, Tennessee, by letter dated
November 11, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
428,000 units of the three sizes were produced.
REASON
Subpotent (stability).
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________
PRODUCT
ELASTIC HEAD STRAP, sold as a standard accessory in the Laerdal
Pocket Mask with Oxygen inlet and headstrap, used to facilitate
exhaled air ventilation in emergencies, whereby the rescuer
exhales air through the mask and into the lungs of the patient.
Recall #Z-264-0.
CODE
Model 830011-33, Lot #13799.
MANUFACTURER
Laerdal Medical AS, Stavanger, Norway.
RECALLED BY
Laerdal Medical Corporation, Wappingers Falls, New York, by
notices dated December 1, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and 1 international facility.
QUANTITY
3,775 units.
REASON
The headstrap of the device contains latex which is not declared
on the label.
________
PRODUCT
Ancure Endograft System, an endovascular catheter designed to
deliver the Endograft and is completely removed from the patient
once Endograft is implanted.
a) The Ancure Tube System, indicated for the endovascular
treatment of infrarenal abdominal aortic aneurysms;
b) The Ancure Bifurcated System, indicated for the endovascular
treatment of infrarenal abdominal aortic or aortic-iliac
aneurysms. Recall #Z-265/266-0.
CODE
a) The Ancure Tube System Part Numbers:
03052009, 03052016, 03052215, 03052414, 03052613
03052010, 03052209, 03052216, 03052415, 03052614
03052011, 03052210, 03052409, 03052416, 03052615
03052012, 03052211, 03052410, 03052609, 03052616
03052013, 03052212, 03052411, 03052610
03052014, 03052213, 03052412, 03052611
03052015, 03052214, 03052413, 03052612
b) The Ancure Bifurcated System Part Numbers:
02042011210, 0204201910, 0204221811, 0204241712, 0204261613
02042011310, 0204201211, 0204221911, 0204241812, 0204261713
02042011410, 0204201311, 0204241212, 0204241912, 0204261813
02042011510, 0204201411, 0204241312, 0204261213, 0204261913
02042011610, 0204201511, 0204241412, 0204261313
02042011710, 0204201611, 0204241512, 0204261413
02042011810, 0204201711, 0204241612, 0204261513
MANUFACTURER
Origin Medsystems, Inc., Menlo Park, California.
RECALLED BY
Manufacturer, by letter on November 17, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
278 units were distributed.
REASON
The monofilament tie, used in the manufacturing process, is not
removed from the endograft prior to completion of the
manufacturing process the attachment system cannot deploy,
leaving the implant in a partial deployed state.
________
PRODUCT
Abbott Alcyon Analyzers with Alcyon System Software Version 1.6.
Recall #Z-267-0.
CODE
List #4E73-04.
MANUFACTURER
Abbott Laboratories, Inc., Irving, Texas.
RECALLED BY
Manufacturer, by telephone on May 18 and 19, 1999, followed by
letter dated May 18, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Japan.
QUANTITY
55 units were distributed.
REASON
The device may give incorrect tests results or reference ranges
when printing the "Complete Report (header)", "Incomplete Report
(DRAFT)", and the "Control Results printout."
_________
PRODUCT
Nellcor Puritan Bennett ventilator, all model #7200 series types,
prescription microprocessor mechanical ventilator which combines
microprocessor technology with a
Pneumatic system to achieve gas delivery and patient monitoring:
a) 7200a series
4-026700-00 7200a domestic English
4-026701-00 7200a international English
4-026702-00 7200a international English
4-026703-00 7200a international French
4-026704-00 7200a international French
4-026705-00 7200a international German
4-026706-00 7200a international Spanish
4-026707-00 7200a international Spanish
4-026708-00 7200a international Japanese
4-026709-00 7200a international Japanese
4-026710-00 7200a international Saudi Arabia
4-026712-00 7200a international Italian
b) 7200sp/spi
4-026720-00 7200sp domestic English
4-026721-00 7200sp 220v/50hz English
4-026722-00 7200sp 240v/50hz English
4-026724-00 7200sp 220v/50hz French
4-026725-00 720spi 220v/50hz German
4-026726-00 720spi 115v/60hz Spanish
4-026727-00 720spi 220v/50hz Spanish
4-026728-00 720spi 100v/50hz Japanese
4-026729-00 720spi 100v/60hz Japanese
4-026730-00 720spi 220v/50hz Saudi Arabia
4-026731-00 720spi 115v/60hz French
4-026732-00 720spi 220v/50hz Italian
c) 7200ae series
4-pb7200-DL 7200ae demo loaner
4-pb7200-DS 7200ae demo sale
4-026734-DP 7200ae w/display
4-026734-00 7200ae w/o display
4-026735-DP 7200 spe w/display
4-026735-00 7200spe w/o display
4-026741-00 7200e. Recall #Z-276/278-0.
CODE
All ventilators with the aforementioned model numbers regardless
of the individual unit's serial number.
MANUFACTURER
Nellcor Puritan Bennett, Inc., a division of Mallinckrodt, Inc.,
Carlsbad, California.
RECALLED BY
Manufacturer, by letter dated June 4, 1999, followed by
telephone. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
46,468 units were distributed.
REASON
The ventilators may deliver an unexpected high inspiratory
pressure and flow when the following set of parameters are
selected at one time: Mode - SIMV, Rate 15, Tidal volume 0.3L,
Peak flow 10 liters/min., Flow pattern = sine wave, Peep =5, and
Fi02 = 0.6.
________
PRODUCT
Various types of human tissue and bone allografts, contained in
either plastic bags or bottles with screw on caps with a computer
generated label:
a) Dura Mater; b) Dura Strips. Recall #Z-284/285-0.
CODE
a) Dura Mater, Tissue Deposit Number AD-24050085-96 (from donor
#APS-2405-95) and Tissue Deposit Number AD-24050086-90 (from
donor #APS-2405-95).
b) Dura Strips, Tissue Deposit Numbers AD24050090-96 and
AD2405088-96 (both from donor #APS-2405-95).
MANUFACTURER
LifeLink Tissue Bank, Tampa, Florida.
RECALLED BY
Manufacturer, by letter dated November 5, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Florida and Alabama.
QUANTITY
4 allografts from one donor are involved.
REASON
The firm did not adequately evaluate the combination of blood and
colloids used in viral market testing and based the hemodilution
determination on the donor's serum total protein.
________
PRODUCT
Bio-Laser Systems, used for biostimulation:
a) Model 1000; b) Model 2000; c) Model TUCO.
Recall #Z-281/283-0.
CODE
Bio-Laser Models 1000, 2000, and TUCO.
MANUFACTURER
Bio-Laser Response Corporaton, Dr. Alvin Stjernholm, Lakewood,
Colorado.
RECALLED BY
Manufacturer. FDA approved the firm's corrective action plan on
December 14, 1999. Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
a) 9 units; b) 1 unit; c) undetermened number units were
distributed.
REASON
The devices failed to comply with 21 CFR 1040.10 and 11 in that
the models have numerous noncompliances.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________
PRODUCT
Patient Cables used in Models: HP M1770A, M1771A, M1772A
PageWriter Electrocardiographs and Model 2488A StressWriter
testing system. Recall #Z-268/271-0.
CODE
All serial numbers.
MANUFACTURER
China Hewlett-Packard Company, Ltd., Qingdao (cables).
RECALLED BY
Agilent Technologies (formerly Hewlett-Packard Co.), Andover,
Massachusetts, by letter on November 12, 1999. Firm-initiated
field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
28,700 units were distributed.
REASON
Damaged cables may lead to distorted ECG waveforms.
________
PRODUCT
PSA Reagent Pack, for the in vitro quantitative measurement of
PSA (Prostate Specific Antigen) in serum and plasma. This test
is used to monitor response to treatment in patients with
prostate cancer and to aid in the identification of recurrence of
prostate cancer prior to manifestation of clinical symptoms. The
PSA Reagent pack is intended for use with the Vitros ECi
Immunodiagnostic System. Recall #Z-272-0.
CODE
Catalog Number 188 6704, Lots 30 and 40.
MANUFACTURER
Fujirebio Diagnostics, Inc., Malvern, Pennsylvania.
RECALLED BY
Ortho-Clinical Diagnostics, Inc., Rochester, New York, by
telephone on June 10, 1999, and by E-mail, FEDEX letter, and fax
on June 8, 1999. Firm-initiated recall complete.
DISTRIBUTION
Virginia and international.
QUANTITY
Lot 30: 371 units; Lot 40: 26 units.
REASON
Microbial contamination of reagent.
________
PRODUCT
ARCHITECT Free T3 Reagent Kit; a Chemiluminescent Microparticle
Immunoassay (CMIA) for the quantitative determination of free
triiodothyronine(Free T3) in human serum and plasma: a) List6C48-
25 - 1 x 100 tests;
b) List 6C48-30 - 4 x 500 tests. Recall #Z-273/274-0.
CODE
List 6C48-30 (2000 test kit), lot 47106M200, 46944M200,
50665M200, 56285M300; List 6C48-25 (100 test kit), lot 47107M200,
49672M100, 46947M200.
MANUFACTURER
Abbott Laboratories, Inc., Abbott Park, Illinois.
RECALLED BY
Manufacturer, by telephone on December 1, 1999, followed by
letter dated November 29, 1999 via Federal Express on December 2,
1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide, Canada, and international.
QUANTITY
1,830 kits were distributed.
REASON
Single analyte high control goes out of specification low,
falling below the concentration range listed in the package
insert.
________
PRODUCT
Greer Dia-Kit, a diagnostic aid for hypersensitivity pneumonitis.
A gel diffusion kit for demonstrating precipitating antibodies.
Recall #Z-275-0.
CODE
Lot K17B-8C-1 and K178B-8C-2.
MANUFACTURER
Greer Laboratories, Inc., Lenoir, North Carolina.
RECALLED BY
Manufacturer, by telephone on October 11, 12, 13, 14, 26, 1999,
November 4 and 8, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
California, Florida, Idaho, Illinois, Massachusetts, North
Carolina, Utah, Virginia.
QUANTITY
42 vials.
REASON
When freeze dried product was reconstituted, the bulk
manufacturing date was not added to the manufacturing record.
This product was given an incorrect expiration date.
________
PRODUCT
Laserflo BPM2 Blood Perfusion Monitor, intended to monitor blood
flow and perfusion. Recall #Z-279-0.
CODE
Serial Numbers: 3401, 3405, 3406, 3407, 3412, 3413, 3414, 3415,
3416, and 3417.
MANUFACTURER
Vasamedics, L.L.C., Little Canada, Minnesota.
RECALLED BY
Manufacturer, by letter dated November 16, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
California, Colorado, Indiana, Missouri, Tennessee, Canada,
Japan, Turkey.
QUANTITY
10 units.
REASON
The devices contain a chip at main circuit board position U47
that does not meet performance specifications due to a chip
substitution error made by a vendor.
________
PRODUCT
Erythropoietin Quantikine IVD Human EPO Immunoassay (ELISA kit),
Catalog number DEP00, used for the in vitro diagnostic
determination of erythropoietin concentration in human serum as
an aid in the diagnosis of anemia and polycythemia. Recall #Z-
280-0.
CODE
Catalog #DEPOO.
Lot Numbers:
9943159 EXP 03Aug00
9944387 EXP 03Aug00
9947180 EXP 03Aug00
9947181 EXP 05Nov00.
MANUFACTURER
R&D Systems, Inc., Minneapolis, Minnesota.
RECALLED BY
Manufacturer, by letter dated December 9, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
546 units were distributed.
REASON
Deterioration of kit components leads to incorrect Erythropoietin
assays.
END OF ENFORCEMENT REPORT FOR DECEMBER 29, 1999.
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