Vaccines, Blood & Biologics
2008 Biologics Recalls
| Date Notification | Brand Name | Product Description | Reason/Problem | Company |
11/13/2008 10/24/2008
| Urgent Medical Device Removal – AXP Processing Bagset-ThermoGenesis | AXP Processing Bagset 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 |
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 | Under specialized situations, the system will save result(s) with incorrect records. | Sunquest Information Systems, Inc. |
9/8/2008 | Important Notification: Red Cell Collection Kits-Haemonetics Corporation | Red Cell Collection Kits Product Code: LN822-00 Product Code: LN832-00 | The numbering sequence may include nine consecutive numbers that match and one that does not. | Haemonetics Corporation |
8/25/2008 | 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. | |
8/22/2008 | Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit) ] - Genzyme Corporation | Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25 mg/vial Lot Number: C7010C01 | Recall of one Thymoglobulin finished product lot based on visual inspection results on stability. | Genzyme Corporation |
8/18/2008 | Monoclate-P®, 1000 Unit Vials Antihemophilic Factor, Human Lot Number: J91504, J91604, J91705 and J91806 | These lots are being withdrawn because they do not meet the potency specification when stored for three months at 5ºC.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 | Monoclate-P®, 1000 Unit Vials Antihemophilic Factor, Human Lot Number: J91504, J91604, J91705 and J91806 | 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 These lots are being withdrawn because they do not meet the potency specification | CSL Behring L.L.C. Bradley, IL | |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 | 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. | |
7/30/2008 | 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 | |
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 | 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. |
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) | Data being entered may be out of sync and saved to a patient other than the one expected. | Sunquest Information Systems, Inc. |
6/12/2008 | 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 | |
6/6/2008 | Bio-Rad Laboratories Multispot HIV-1/HIV-2 Rapid Test Catalog Number 25228 Lot Number Expiration Date | The package insert provided with the above listed lots contains a typographical insert. | Bio-Rad Laboratories | |
6/5/2008 | 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) | 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. | |
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 |
4/30/2008 | Plasbumin-5 Albumin (Human) 5%, USP Lot Number: 26N9P21 | 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 | This lot of AUSAB EIA has reduced sensitivity using Procedure A incubation method. | Abbott Laboratories |
4/21/2008 | Blood Grouping Reagent Anti-S for Indirect Antiglobulin Tests Lot SS188C (Expiration Date May 6, 2008) | Company has received complaints of weakened reactivity or false negative reactions for the positive controls when using these lots. | Ortho Clinical Diagnostics, Inc. (OCD) | |
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 | 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. |
4/9/2008 | Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)]-Genzyme Corporation | Anti-thymocyte Globulin (Rabbit) 25 mg/vial Lot Numbers: | 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 |
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 | 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. |
2/26/2008 | Medical Device Notification: Filtered Red Cell Disposable Kits-Haemonetics Corporation | Filtered Red Cell Disposable Kits | Haemonetics has recently discovered a label discrepancy in lot number A08059 of their filtered red cell disposable kits, LN 832F. | Haemonetics Corporation |
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 | 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 |
2/12/2008 | Uni-Gold Recombigen HIV Product Number: 1206506 | There is a potential of false positive results on negative patients samples, while negative results remain true negatives. | Trinity Biotech USA | |
2/11/2008 | Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2 | 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. | |
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 | This recall was initiated when Thymoglobulin, lot CG024CAA failed a periodic stability test based upon appearance of the reconstituted product. | Genzyme Corporation |
1/29/2008 | Recall of Hymenoptera (Honey Bee) Venom Products - Hollister-Stier Laboratories | Honey Bee Venom Maintenance Dose Set Diagnostic Set | 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 |
1/23/2008 | Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2 | 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. | |
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 |
