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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2008 Biologics Recalls

Date NotificationBrand NameProduct DescriptionReason/ProblemCompany

11/13/2008

10/24/2008

 

Urgent Medical Device Removal – AXP Processing Bagset-ThermoGenesis

AXP Processing Bagset
Model 8-5101

Lot Numbers: 08A29, 08B13, 08B20, 08B25, 08C04, and 08C11

They have become aware that particulates from the stopcock in the bagset may be released into the sterile, non-pyrogenic fluid path.

Thermogenesis Corporation
Rancho Cordova, CA

9/30/2008

Medical Device Notification (PSN-08-09)-Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc.

Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2
Distributed with Sunquest Laboratory v6.1, v6.2, v6.3

Under specialized situations, the system will save result(s) with incorrect records.

Sunquest Information Systems, Inc.
Tucson, Arizona

9/8/2008

Important Notification: Red Cell Collection Kits-Haemonetics Corporation

Red Cell Collection Kits

Product Code: LN822-00
Lot Number  Expiration Date
E08099         5/2011
E08102         5/2011
F08158         6/2011
F08163         6/2011
F08169         6/2011
F08175         6/2011

Product Code: LN832-00
Lot Number Expiration Date
E08200         5/2011
E08208         5/2011
F08052         6/2011
F08062         6/2011
F08071         6/2011
F08079         6/2011
F08098         6/2011
F08108         6/2011
F08119         6/2011
F08129         6/2011
F08133         6/2011
F08190         6/2011
F08193         6/2011
F08201         6/2011
F08208         6/2011
F08211         6/2011
G08096        7/2011
G08104        7/2011
G08114        7/2011

The numbering sequence may include nine consecutive numbers that match and one that does not.

Haemonetics Corporation
Braintree, Massachusetts

8/25/2008

Recall of m2000sp Instrument-Abbott Molecular, Inc.

Hood Assembly for the Abbott m2000sp (List 9K14-01 and 9K14-02) Automated Sample Preparation System

Customers are asked to take care to monitor the adhesion of the hood front window to the window stud plates.

Abbott Molecular, Inc.
Des Plaines, Illinois

8/22/2008

Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit) ] - Genzyme Corporation

Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25 mg/vial
NDC# 58468-0080-1

Lot Number: C7010C01
Expiration Date: April 2010

Recall of one Thymoglobulin finished product lot based on visual inspection results on stability.

Genzyme Corporation
Framingham, Massachusetts

8/18/2008

Field Correction for Component Pack packaged with Mononine (Coagulation Factor IX, Human)-CSL Behring

Monoclate-P®, 1000 Unit Vials Antihemophilic Factor, Human

Lot Number: J91504, J91604, J91705 and J91806
Expiration Date: April 25, April 30, May 2 and June 9, 2010

These lots are being withdrawn because they do not meet the potency specification when stored for three months at 5ºC.

CSL Behring L.L.C. Bradley, IL

8/18/2008

Recall: Antihemophilic Factor, Human - CSL Behring L.L.C.

Monoclate-P®, 1000 Unit Vials Antihemophilic Factor, Human

Lot Number: J91504, J91604, J91705 and J91806
Expiration Date: April 25, April 30, May 2 and June 9, 2010

Voluntary Recall of four lots of Monoclate-P®, Antihemophilic Factor, Human. These lots are being withdrawn because they do not meet the potency specification

CSL Behring L.L.C. Bradley, IL

8/15/2008

Medical Device Notification (PSN-08-06) - Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc.

Sunquest Blood Bank and Blood Donor version 6.0.1 distributed with Sunquest Laboratory 6.1 and 6.2; Sunquest Blood Bank and Blood Donor version 6.0.2 distributed with Sunquest Laboratory 6.3

In the Blood Order Processing module when at least two tests are added to a unit in the Compatibility Testing window, under specialized situations, the system will save result(s) with incorrect records.

Sunquest Information Systems, Inc.
Tucson, Arizona

7/30/2008

Recall of m2000sp Instrument-Abbott Molecular

Solid Waste Chute (DiTi Slide) for use with the Abbott m2000sp (List 9K14-01 and 9K14-02) Automated Sample Preparation System

Abbott has recently identified that the solid waste chute (DiTi Slide 04J72-29) may have sharp edges.

Abbott Molecular
Des Plaines, IL

7/28/2008

Medical Device Notification (PSN-08-08) - Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc.

Sunquest Laboratory Blood Bank and Blood Donor Modules v6.01 and v6.02
Distributed with Sunquest Laboratory v6.1, v6.2 and v6.3

In the Blood Order Processing module, when the unit compatibility grid is enabled and under specialized situations, the system does not trigger all Quality Assurance messages.

Sunquest Information Systems, Inc.
Tucson, Arizona

6/24/2008

Medical Device Notification (PSN-08-05) - Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest InformationSystems, Inc.

Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2, and v6.4.0 (Beta)
Distributed with Sunquest Laboratory v6.1, v6.2, v6.3 and v6.3.1 (Beta)

Data being entered may be out of sync and saved to a patient other than the one expected.

Sunquest Information Systems, Inc.
Tucson, Arizona

6/12/2008

Correction of AUSZYME Monoclonal Assay-Abbott Laboratories

AUSZYME Monoclonal - List Number 1980

Lot Numbers: 64421M100, 64421M102, 64422M100, 64422M102, 64423M100, 64425M100, 64425M101

Recent product stability data indicate that lots 64425M100 and 64425M101 are not meeting Abbott's internal low-level HBs antigen sensitivity requirement.

Abbott Laboratories
Abbott Park, IL

6/6/2008

Urgent Product Correction - Bio-Rad Laboratories Multispot HIV-1/HIV-2 Rapid Test - Bio-Rad Laboratories

Bio-Rad Laboratories Multispot HIV-1/HIV-2 Rapid Test

Catalog Number 25228

Lot Number    Expiration Date
949779            7/30/08
950636            9/18/08
950988            10/12/08
952077            11/29/08
952635            1/3/09
953287            1/30/09

The package insert provided with the above listed lots contains a typographical insert.

Bio-Rad Laboratories
Redmond, Washington

6/5/2008

Medical Device Notification (PSN-08-03) - Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc.

Sunquest Laboratory Blood Bank and Blood Donor Modules v5.2
Distributed with Sunquest Laboratory v5.3. and v5.4

Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2, and v6.4.0 (Beta)
Distributed with Sunquest Laboratory v6.1, v6.2, v6.3 and v6.3.1 (Beta)

In both the Blood Bank and Blood Donor modules, a problem has been identified when a pooled unit is pooled with another unit.

Sunquest Information Systems, Inc.
Tucson, Arizona

5/7/2008

Medical Device Recall: BioArchive (Vapor Bypass Assembly)-Thermogenesis Corporation

BioArchive Vapor Bypass Assembly (110v / 220v)

The BioArchive system is a computer-controlled, robotic liquid nitrogen cryopreservation and storage system that enables the freezing and managing of blood component samples.

Thermogenesis Corporation
Rancho Cordova, CA

4/30/2008

Withdrawal of Albumin (Human) 5 %-Talecris Biotherapeutics

Plasbumin-5     Albumin (Human) 5%, USP

Lot Number: 26N9P21
Expiration Date: March 7, 2011

The lot is being withdrawn due to internal audit findings at the plasma collection facility that provided the Source Plasma used to produce this product lot.

Talecris Biotherapeutics Clayton, North Carolina

4/21/2008

Product Correction: Hepatitis B Surface Antigen AUSAB EIA-Abbott Laboratories

Hepatitis B Surface Antigen AUSAB EIA

List Number: 9006-24
Lot Number: 59238M200
Expiration: June 11, 2008

This lot of AUSAB EIA has reduced sensitivity using Procedure A incubation method.

Abbott Laboratories
Abbott Park, IL

4/21/2008

Important Product Correction Notification: Blood Grouping Reagent Anti-S for Indirect Antiglobulin Tests - Ortho Clinical Diagnostics, Inc

Blood Grouping Reagent Anti-S for Indirect Antiglobulin Tests
Product Code 723030

Lot SS188C (Expiration Date May 6, 2008)
Lot SS188D (Expiration Date July 24, 2008 )
Lot SS189A (Expiration Date October 30, 2008)
Lot SS189B (Expiration Date January 23, 2009)
Lot SS189C (Expiration Date April 8, 2009)

Company has received complaints of weakened reactivity or false negative reactions for the positive controls when using these lots.

Ortho Clinical Diagnostics, Inc. (OCD)
Raritan, New Jersey

4/18/2008

Recall of Rho(D) Immune Globulin (Human); Hyper RHO S/D, Mini-Dose-Talecris Biotherapeutics, Inc

Rho(D) Immune Globulin (Human); HyperRHO S/D, Mini-Dose

Lot Number: 26N7XX1
Expiration: June 29, 2009
NDC Number: 13533-631-06

This lot of HyperRHO S/D, Mini-Dose is currently testing less than the full potency of 250 IU/dose as labeled.

Talecris Biotherapeutics, Inc.
Clayton, North Carolina

4/9/2008

Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)]-Genzyme Corporation

Anti-thymocyte Globulin (Rabbit) 25 mg/vial
NDC # 58468-0080-1
 

Lot Numbers:
C7014C01 (Expires May 31, 2010)
C7008C01 (Expires March 31, 2010)
TH175-05 (Expires October 4, 2009)

This recall was initiated when Thymoglobulin lot C7014C01 failed a periodic stability test based upon appearance of the reconstituted product. The 2 additional lots involved in this recall, lot numbers TH175-05 and C7008C01, are being recalled based on a predicted stability failure for appearance prior to the labeled expiration dates.

Genzyme Corporation
Framingham, Massachusetts

3/26/2008

Medical Device Notification: Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc

Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2
Distributed with Sunquest Laboratory v6.1, v6.2 and v6.3

In both the Blood Bank and Blood Donor modules, a problem has been identified when a pooled unit is pooled with another unit.

Sunquest Information Systems, Inc.
Tucson, Arizona

2/26/2008

Medical Device Notification: Filtered Red Cell Disposable Kits-Haemonetics Corporation

Filtered Red Cell Disposable Kits
List Number: 832F
Lot Number: A08059

Haemonetics has recently discovered a label discrepancy in lot number A08059 of their filtered red cell disposable kits, LN 832F.

Haemonetics Corporation
Braintree, Massachusetts

2/19/2008

Recall of ThermoGenesis AXP Bag Sets 8-5101-ThermoGenesis Corporation

Disposable Processing Set for the AXP System 8-5101 (Box of 24)

Lot Number/Expiration
25128-0674-05/Oct-08; 25128-0674-04/Oct-08; 25128-0671-03/Oct-08; 25128-0669-02/Oct-08; 25128-0667-01/Sep-08; 24455-0666-04/Aug-08; 24455-0665-03/Aug-08; 24455-0663-02/Sep-08; 24452-0661-05/Aug-08; 24452-0659-04/Sep-08; 24452-0655-02/Jul-08; 24452-0653-01/Aug-08; 24452-0000-03/Aug-08; 24455-0661-01/Aug-08; 22129-0640-04/Jul-08; 22129-0639-03/May-08; 22129-0633-01/Apr-08; 22128-0633-04/Apr-08; 22128-0631-03/Apr-08; 22128-0625-01/Mar-08; 22127-0623-04/Apr-08; 22127-0621-03/Mar-08; 22127-0619-02/Apr-08; 22127-0617-01/Apr-08; 21504-0617-03/Apr-08; 21504-0615-02/Mar-08; 21504-0614-01/Mar-08; 20684-0613-16/Mar-08; 20684-0611-15/Mar-08; 20684-0609-14/Mar-08; 20684-0607-13/Feb-08; 20684-0605-12/Feb-08; 20684-0603-11/Feb-08; 20684-0601-10/Feb-08; 20684-0599-09/expired; 20684-0597-08/expired; 20684-0595-07/expired; 0684-0593-06/expired; 0684-0588-02/expired; 20684-0586-01/expired; 20338-0586-02/expired; 20337-0000-03/expired; 20337-0000-02/expired; 20337-0000-01/expired; 19863-0000-04/expired; 19863-0000-03/expired; 19863-0000-02/expired; 19863-0000-01/expired; 19329-0584-03/expired; 19329-0000-06/expired; 19329-0000-05/expired; 19329-0000-04/expired; 19329-0000-03/expired; 18279-0000/expired; 17882-0000/expired; 16988-0000/expired; 16978-0000/expired; 16359-0000/expired; 16357-0000/expired; 15500-0000/expired; 15357-0000/expired; 15118-0000/expired; 15021.00/expired

ThermoGenesis has discovered that some lots of its AXP Bag Sets 8-5101 were distributed prior to the performance of endotoxin (pyrogen) testing. These lots were not assayed for endotoxins with Limulus Amebocyte Lysate (LAL) as a manufacturing release test.

ThermoGenesis Corporation
Rancho Cordova, CA

2/12/2008

Recall of Uni-Gold Recombigen HIV-Trinity Biotech USA

Uni-Gold Recombigen HIV

Product Number: 1206506
Lot Number: R288013
Expiration Date: October 2, 2008

There is a potential of false positive results on negative patients samples, while negative results remain true negatives.

Trinity Biotech USA
Jamestown, New York

2/11/2008

Medical Device Notification: Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc.

Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2
Distributed with Sunquest Laboratory v6.1, v6.2 and v6.3

In both the Blood Bank and Blood Donor modules, a problem has been identified in Blood Order Processing. The system does not trigger all Quality Assurances messages when reaction result grids are enabled.

Sunquest Information Systems, Inc.
Tucson, Arizona

2/11/2008

Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)]-Genzyme Corporation-2/11/08

Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25mg/vial
 

NDC# 58468-0080-1
Lot Number: CG024CAA
Expiration Date: Nov 2009

This recall was initiated when Thymoglobulin, lot CG024CAA failed a periodic stability test based upon appearance of the reconstituted product.

Genzyme Corporation
Framingham, Massachusetts

1/29/2008

Recall of Hymenoptera (Honey Bee) Venom Products - Hollister-Stier Laboratories

Honey Bee Venom
Apis mellifera Venomil

Maintenance Dose Set
Item Code: 6781U2
Set Lot Number: M11316D
Expiration Date: 1/1/2010
Set contains 6 Honey Bee Vials

Diagnostic Set
Item Code: 6781U0
Set Lot Number: D11316C
Expiration Date: 1/1/2010
Set contains 1 Honey Bee Vial

This product is being voluntarily recalled because the Honey Bee Venom vials in these packages state an incorrect strength on the vial label.

Hollister-Stier Laboratories, LLC
Spokane, Washington

1/23/2008

Recall of Medical Device Notification: Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2-Sunquest Information Systems, Inc.

Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2
Distributed with Sunquest Laboratory v6.1, v6.2 and v6.3

If the user chooses to delete and unacceptable product test result by replacing it with another unacceptable product test result, then cancels and saves, the system incorrectly retains the initial result instead of leaving the product test pending.

Sunquest Information Systems, Inc.
Tucson, Arizona

1/7/2008

Recall of White-Faced Hornet Venom Protein - Hollister-Stier Laboratories LLC

White-Faced Hornet Venom Protein / 1132101C / June 18, 2010

The product is being voluntarily recalled because the incorrect overseal was used.

Hollister Stier Laboratories LLC
Spokane, Washington