Enforcement Report

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.

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December 15, 2004
04-50

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

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PRODUCT
Appledore Smoked Foods Premium Smoked Atlantic Salmon, 4 oz frozen Vacuum Packed Product Number: 15253 and 8 oz Frozen, Vacuum Packed Product Number: 15252. Recall # F-085-5.
CODE
Lot Number: 42588/1967.
RECALLING FIRM/MANUFACTURER
True North Salmon Co. Ltd., St. George, New Brunswick, Canada, by fax on October 22, 2004. Firm initiated recall is complete.
REASON
Product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
206 lbs.
DISTRIBUTION
NY.

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PRODUCT
a) Schwan’s Breaded and Precooked Haddock Squares,
1.5 lb box, Item #548D ***. Recall # F-086-5;
b) Schwan’s Breaded and Parfried Haddock Squares,
1.5 lb box, Item #548 ***. Recall # F-087-5;
c) Schwan's Breaded and Precooked Haddock Sticks,
1.25 lb bag, Item #547D *** Recall # F-088-5;
d) Schwan’s Breaded and Parfried Haddock Sticks,
1.25 lb box, Item #547*** Recall # F-089-5.
CODE
a) All codes beginning with “W” and the following
5 digits: Fish Squares: W54280xxxx, W54237xxxx,
W54161xxxx, W54149xxxx, W54133xxxx, W54103xxxx,
W54098xxxx, W54010xxxx, W54013xxxx, W53342xxxx,
W53308xxxx******* Fish Sticks: W54218xxxx,
W54132xxxx, W54142xxxx, W54097xxxx, W54033xxxx,
W53344xxxx, W53336xxxx, W53317xxxx, W53286xxxx;
b) All codes beginning with "W" and the following
5 digits: Fish Squares: W54280xxxx, W54237xxxx,
W54161xxxx, W54149xxxx, W54133xxxx, W54103xxxx,
W54098xxxx, W54010xxxx, W54013xxxx, W53342xxxx,
W53308xxxx******* Fish Sticks: W54218xxxx,
W54132xxxx, W54142xxxx, W54097xxxx, W54033xxxx,
W53344xxxx, W53336xxxx, W53317xxxx, W53286xxxx;
c) All codes beginning with “W” and the following
5 digits: Fish Squares: W54280xxxx, W54237xxxx,
W54161xxxx, W54149xxxx, W54133xxxx, W54103xxxx,
W54098xxxx, W54010xxxx, W54013xxxx, W53342xxxx,
W53308xxxx******* Fish Sticks: W54218xxxx,
W54132xxxx, W54142xxxx, W54097xxxx, W54033xxxx,
W53344xxxx, W53336xxxx, W53317xxxx, W53286xxxx;
d) All codes beginning with “W” and the following
5 digits: Fish Squares: W54280xxxx, W54237xxxx,
W54161xxxx, W54149xxxx, W54133xxxx, W54103xxxx,
W54098xxxx, W54010xxxx, W54013xxxx, W53342xxxx,
W53308xxxx******* Fish Sticks: W54218xxxx,
W54132xxxx, W54142xxxx, W54097xxxx, W54033xxxx,
W53344xxxx, W53336xxxx, W53317xxxx, W53286xxxx.
RECALLING FIRM/MANUFACTURER
Iceland Seafood Corp., Newport News, VA, by telephone on October 15, 2004 and by letter on October 25, 2004. Firm initiated recall is ongoing.
REASON
Frozen breaded fish products may contain undeclared whey.
VOLUME OF PRODUCT IN COMMERCE
548,160 consumer units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

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PRODUCT
a) SportsOne Androstenedione 100 mg, 100 capsules Label
reads in part: *** SPORTS ONE * ANDROSTENEDIONE *
100 mg. DIETARY SUPPLEMENT * 100 capsules * Ingredients:
Each ... 100 mg. of Androstenedione. * Warning:
Androstenedione should not be used, Recall # F-090-5;
b) SportsOne ANDRO XS 600 mg, 60capsules Label reads
in part: SPORTS ONE * ANDRO * XS * Androstenedione
Tribulus Terrestris 600 mg. * 60 capsules *
Androstenedione 100 mg * Tribulus Terrestris 500 mg *
DIETARY SUPPLEMENT * Warning: This product should
not be used... * Recall # F-091-5.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Sports One Inc., New Haven, CT, by AP press release on March 11, 2004 and website on March 12, 2004. Firm initiated recall is complete.
REASON
The product is adulterated since it contains the new dietary ingredient, androstenedione, for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide.

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PRODUCT
a) King B Belgian Waffles #5072, frozen, 72 x 2-oz
packages in each cardboard carton. Recall # F-092-5;
b) King B Belgian Waffles #5018, frozen, 36 x 5-oz
packages in each cardboard carton. Recall # F-093-5.
CODE
All product that does not bear an ingredient statement.
RECALLING FIRM/MANUFACTURER
Waffle Man, Inc., Enid, OK, by e-mail on October 28, 2004. Firm initiated recall is ongoing.
REASON
The waffles do not bear an ingredient statement and contain undeclared allergens wheat, eggs, and milk.
VOLUME OF PRODUCT IN COMMERCE
21,357 cases.
DISTRIBUTION
Nationwide and Canada.

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PRODUCT
a) Your Cake Connection brand, “Marble Cake with Cream
Cheese Icing & Decorative Roses” 54 ounce and
56 ounce size cakes. Recall F-094-5;
b) Your Cake Connection brand, “Red Velvet Cake
with Cream Cheese Icing & Decorative Roses”
48 ounce size cakes. Recall F-095-5.
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
INTER American Products Inc., Cincinnati, OH, by fax and e-mail on September 17, 2004. Firm initiated recall is ongoing.
REASON
Cakes contain undeclared colors - FD&C yellow No. 5 and yellow No, 6.
VOLUME OF PRODUCT IN COMMERCE
135,937 cakes.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
Source Plasma. Recall # B-0241-5.
CODE
Unit number: 02RVAB3021.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Richmond, VA, by facsimile on November 14, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

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PRODUCT
Fresh Frozen Plasma. Recall # B-0293-5.
CODE
Unit 0174576.
RECALLING FIRM/MANUFACTURER
Marquette General Hospital, Inc., Marquette, MI, by telephone on April 30, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was taking the drug Desmopressin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

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PRODUCT
a) Red Blood Cells. Recall # B-0294-5;
b) Red Blood Cells Leukocytes Reduced. Recall # B-0295-5;
c) Platelets, Recall # B-296-5;
d) Platelets Leukocytes Reduced. Recall # B-297-5;
e) Fresh Frozen Plasma, Reall # B-298-5;
f) Recovered Plasma, Recall # B-299-5.
CODE
a) and c) Units 042X38219, 042X25534, 042K01884,
042FP10993, 042X36285, 042X13288, 042W62587,
042G81622 and 042L75294;
b) and d) Unit 042X76460;
e) Units 042X38219 and 042X13288;
f) Units 042X76460, 042X25534, 042K01884,
042FP10993, 042X36285, 042W62587, 042G81622
and 042L75294.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by telephone on March 2 and 4, 2004, and by letter dated March 10, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had close contact with an individual that had a history of a positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units.
DISTRIBUTION
OH and NY.

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PRODUCT
Source Plasma. Recall # B-0300-5.
CODE
Unit G-29028-093.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Brownsville, TX, by facsimile dated September 24, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who had a tattoo applied within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0305-5.
CODE

RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeShare Blood Centers, Shreveport, Louisiana, by telephone on June 23, 2004.
Manufacturer: LifeShare Blood Centers, Alexandria, Louisiana. Firm initiated recall is complete.
REASON
Platelets, prepared with an insufficient plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

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PRODUCT
Source Plasma. Recall # B-0306-5.
CODE
Units HM056710, HM056377, HM056227, HM056067, HM055930, HM055779, HM055662, HM055211, HM055062, HM054335, HM054052, HM039752, HM039448.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Houma, Louisiana, by facsimile dated July 19, 2002. Firm initiated recall is complete.
REASON Source Plasma, collected from a donor who had tattoos applied within the past 12 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 UNITS.
DISTRIBUTION
NC.

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PRODUCT
Human Corneal Tissue for Transplantation. Recall # B-0314-5.
CODE
MSN-2003-0461 & MSN-2003-0462.
RECALLING FIRM/MANUFACTURER
The Lions Eye Bank of Wisconsin, Inc., Madison, WI, by telephone on July 23, 2003. 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 anti-hepatitis C virus (anti-HCV) and antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2) by a different facility, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
WI.

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PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced. Recall # B-0325-5.
CODE
Unit number 4182338 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on February 5, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to recent dental surgery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0328-5.
CODE
Unit number 01GN75532.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY, by telephone and letter on November 6, 2003.
Manufacturer: American Red Cross Blood Services, Syracuse, NY. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history interview did not have documentation of answers to the medical history questions related to risk factors for Creutzfeldt-Jacob disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.

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PRODUCT
a) Red Blood Cells, Recall # B-0329-5;
b) Recovered Plasma, Recal # B-0330-5.
CODE
a) and b) Unit number 31K76559.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY, by letter and facsimile on November 13, 2003, and December 16, 2003.
Manufacturer: American Red Cross Blood Services, Buffalo, NY. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA, and Switzerland.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0331-5.
CODE
Unit numbers LE81108, LE98489, and FG99732.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on September 21, 2004. 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
3 units.
DISTRIBUTION
RI, NY, and MA.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0332-5.
Problem:&
CODE
Unit number 1670933 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, Inc., East Orange, NJ, by telephone on February 1, 2004. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0333-5.
CODE
Unit number 13FF46327.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region,Detroit, MI , by telephone on July 13, 2004, and by letter on August 5, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that was possibly contaminated with coagulase negative Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

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PRODUCT
Red Blood Cells, Recall # B-0334-5.
CODE
Unit number 13LC78722.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on May 19, 2004, and by letter on August 5, 2004. Firm initiated recall is complete.
REASON
Blood product, that tested elevated for alanine aminotransferase (ALT), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

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PRODUCT
Red Blood Cells, Irradiated, Recall # B-0335-5.
CODE
Unit number 6854283.
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, Inc., East Orange, NJ, by telephone on February 27, 2003. Firm initiated recall is complete.
REASON
Blood product, for which documentation of irradiation was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

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PRODUCT
TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.02, Catalog Numbers 019359, 019400; Model 019400, Smart Media. Recall # Z-0218-05.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Tosoh Bioscience, Inc., San Francisco, CA, by telephone on April 2, 2003. Software upgrade was performed by firm’s Field Service Engineers. Firm initiated recall is complete.
REASON
A software upgrade was released by the firm for its AIA-600 II analyzers, in that washing deficiencies caused by the analyzer were corrected.
VOLUME OF PRODUCT IN COMMERCE
81 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT
IDEAL SOFT® (polymacon) Hydrophic contact lens, 62% poly (2-hydroxyethlymethacrytate). 38% water immersed in 0.9% sodium chloride solution. One sterile. Recall # Z-0221-05.
CODE
Lot numbers: QG03, QG10, QG19, QH06, QH09, QH14, QI05, QI11, QI20, QJ14, QJ15, QF27, QG29, QI25, QH08 QH22 & SF23.
RECALLING FIRM/MANUFACTURER
Ideal Optics, Inc, Atlanta, GA, by letter on October 13, and November 8, 2004. Firm initiated recall is ongoing.
REASON
Lenses may not be sterile.
VOLUME OF PRODUCT IN COMMERCE
1,764 vials.
DISTRIBUTION
AL, GA, NC, NY, SC, VA.

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PRODUCT
LifePort®, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255. Catalog #LPS 7255m. Recall # Z-0256-05.
CODE
Kit # 20474.
RECALLING FIRM/MANUFACTURER
Horizon Medical Products, Inc., Manchester, GA, by letter on September 20, 2004. Firm initiated recall is ongoing.
REASON
The product has an incorrectly sized introducer included in the kit. The kit contains a 12 French introducer instead of a 7 French introducer.
VOLUME OF PRODUCT IN COMMERCE
44 kits.
DISTRIBUTION
FL, GA, LA, MD, NJ, OK, TX and VA.

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PRODUCT
Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK. Recall # Z-0257-05.
CODE
Lot Numbers 38821 through 45666 for each catalog number, Expiration Date October 2008.
RECALLING FIRM/MANUFACTURER
Medrad Inc., Indianola, PA, by letters dated November 1, 2004. Firm initiated recall is ongoing.
REASON
Sterility can be compromised by a tear in the outer packaging.
VOLUME OF PRODUCT IN COMMERCE
875,798 kits.
DISTRIBUTION
Nationwide and Internationally.

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PRODUCT
Alsius CoolGard 3000 patient temperature regulation system. Recall # Z-0258-05.
CODE
Serial numbers 30000160 and 30000132.
RECALLING FIRM/MANUFACTURER
Alsius Corporation, Irvine, CA, by firm representative on November 10, 2004. Firm initiated recall is complete.
REASON
Product alarms that there may be a power supply interruption.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL and NC.

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PRODUCT
XPRT Therapy Mattress Systems: Model # 2950-000-000 with Dartex urethane-coated nylon cover (deluxe cover); and Model # 2950-000-001 with nylon cover without coating (standard cover). Responsible firm on the label: Manufactured for STRYKER MEDICAL, 6300 South Sprinkle Road, Kalamazoo, MI USA 49001-9799, 1-800-327-0770. The unit consists of a sleep surface, an integrated valve box located in the head of the mattress, a pump box located under the foot of the mattress and a color touch screen controller that can be mounted to either side of the pump box at the foot end of the mattress. Recall # Z-0260-05.
CODE
The following serial numbers, which represent all units shipped: H40001 thru H40038; and I40001, I40003, I40004, I40005, I40006, I40009, I40012, I40013, I40014, I40017, I40018, and I40021.
RECALLING FIRM/MANUFACTURER
Gaymar Industries, Inc, Orchard Park, NY, by letter dated October 25, 2004. Firm initiated recall is ongoing.
REASON
Design control/validation deficiencies.
VOLUME OF PRODUCT IN COMMERCE
48 units.
DISTRIBUTION
NE and HI.

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PRODUCT
AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer, stabilizers and calcium chloride. Recall # Z-0261-05.
CODE
Lot number M13906, Exp. 6/14/06.
RECALLING FIRM/MANUFACTURER
Trinity Biotech USA, Jamestown, NY, by letters dated November 1, 2004. Firm initiated recall is ongoing.
REASON
Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value.
VOLUME OF PRODUCT IN COMMERCE
1,183 kits.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465. Recall # Z-0262-05.
CODE
Part number: 465101 Lot Numbers - Date of Mfg - Expiration Date M310237 - 10/29/2003 - 10/31/2004 M401010 - 01/15/2004 - 01/31/2005 M403026 - 03/05/2004 - 03/31/2005 M406041 - 06/10/2004 - 06/30/2005.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter on October 25, 2004. Firm initiated recall is ongoing.
REASON
Beckman Coulter has confirmed that occasionally a cuvette may be skipped during the SYNCHRON Lipase Wash (LIWA) procedure. If this occurs, there is the potential for carryover into the SYNCHRON Lipase (LIPA) assay, resulting in a substantial positive bias affecting Lipase (LIPA) results.
VOLUME OF PRODUCT IN COMMERCE
6,698.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system. Recall # Z-0263-05.
CODE
Serial Number: B0071; B0095; B0055; B0060; B0124; B0131; B0097; B0106; B0064; B0087; B0073; B0113; B0121; B0135; B0122; B0123; B0102.
RECALLING FIRM/MANUFACTURER
DPC Cirrus, Flanders, NJ, by e-mail and fax on October 22, 2004. Firm initiated recall is ongoing.
REASON
Erroneous handling of samples will cause problems after the system is placed in “Sample-pause”.
VOLUME OF PRODUCT IN COMMERCE
83 units.
DISTRIBUTION
Nationwide and Internationally.

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PRODUCT
3M nexcare First Aid HoldFast Roll Gauze, Catalog number HF-2R. 1 Roll, 2 in. x 4.1 yards (stretched). Immediate product packaging (formed plastic with paper cover) contains no labeling. Recall # Z-0264-05.
CODE
Lot # 4267.
RECALLING FIRM/MANUFACTURER
3M Company/Medical Division, South St. Paul, MN, by letter dated November 5, 2004. Firm initiated recall is ongoing.
REASON
Mislabeled - Nexcare Holdfast Roll Gauze were not sterilized, the product is labeled with "Sterility Guaranteed Unless Package is Opened or Damaged".
VOLUME OF PRODUCT IN COMMERCE
3,528 rolls.
DISTRIBUTION
Nationwide and Guam.

_______________________________
PRODUCT
Access Immunoassay Systems, Discrete photometric chemistry analyzer. Recall # Z-0265-05.
CODE
Access 2 Immunoassay Systems Part Number 81600N software versions 20., 2.1, and 2.2. Access Immunoassay Systems Chlamydia Reagent Kit Part Number 34401.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter on November 8, 2004. Firm initiated recall is ongoing.
REASON
A rare condition of the Access 2 Immunoassay Systems software versions 2.0, 2.1 and 2.2 could present a risk of an erroneous confirmatory result under a specific set of circumstances. The Chlamydia Blocking results may be affected. The instrument will erroneously perform the blocking calculation on the affected test by using the mean of the diluted and neat results.
VOLUME OF PRODUCT IN COMMERCE
1,197 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
BD™ Phoenix™ ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600, and 448708, packaged in cartons of 25 panels. Recall # Z-0268-05.
CODE
Lots: 3316699 11/30/2004 4146868 05/31/2005 4063959 03/31/2005 4231466 08/31/2005 3288384 10/31/2004 3316697 11/30/2004 4035990 02/28/2005 4063276 03/31/2005 4133618 05/31/2005 4203249 07/31/2005 4209161 08/31/2005 4245919 09/30/2005 4231472 08/31/2005 4181008 07/31/2005 4224731 08/31/2005 4231473 08/31/2005 4224708 08/31/2005.
RECALLING FIRM/MANUFACTURER
Becton Dickinson and Company, Sparks, MD, by letter on October 29, 2004. Firm initiated recall is ongoing.
REASON
The foil pouch containing an in vitro diagnostic test kit for bacteria identification in patient samples may be defective and cause incorrect patient results.
VOLUME OF PRODUCT IN COMMERCE
1,250 cartons of 25 units/carton.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
CXP software for Cytomics FC500 Cytometer. Recall # Z-0266-05.
CODE
Versions 1.0, 1.1, and 2.0.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter of November 8, 2004. Firm initiated recall is ongoing.
REASON
Incorrect sample identification can be displayed and printed on the Runtime Panel Report due to a software defect.
VOLUME OF PRODUCT IN COMMERCE
167.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
DL2000 Data Manager Software, Version 6.4.108. Recall # Z-0267-05.
CODE
Version 6.4.108.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letters on November 5, 2004. Firm initiated recall is ongoing.
REASON
Possibility of reporting an incorrect result occurs due to a software anomally.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
FL, IL, and CA.

END OF ENFORCEMENT REPORT FOR December 15, 2004

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