Vaccines, Blood & Biologics
2004 Biologics Recalls
| Date Notification | Brand Name | Product Description | Reason/Problem | Company |
|---|---|---|---|---|
| 12/17/2004 | Recall of Leukocyte Reduction BPF4 High Efficiency Filter- Pall Medical Corp | LOT NUMBERS: Product Code 430-41 0450481 Product Code 430-50 0450574 Product Code BPFB 0450615 | Pall Medical has received reports of hemolysis in the attached segment tubing and the storage bags observed at varying times following filtration using this product. | Pall Medical Corporation |
| 10/18-26/2004 | Notice of Field Correction: Automated Blood Cell Separator, Haemonetics Mobile Collection Systems Update-Haemonetics Corp | Automated Blood Cell Separator, Haemonetics Mobile Collection Systems Model Numbers | Haemonetics is aware of the possibility when using an MCS machine that a small leak at the base of the Latham bowl may cause the collection of blood from a donor to exceed the recommended extracorporeal volume limit. | Haemonetics Corporation |
| 10/18-26/2004 | Notice of Field Correction: Automated Blood Cell Separator, Haemonetics LN9000 Mobile Collection System-Haemontics Corp | Automated Blood Cell Separator, Haemonetics LN9000 Mobile Collection System | Haemonetics is aware of the possibility when using an MCS machine that a small leak at the base of the Latham bowl may cause the collection of blood from a donor to exceed the recommended extracorporeal volume limit. | Haemonetics Corporation |
| 9/20/2004 | Recall of ORTHO Antibody to HBsAg ELISA Test System 3-Ortho Clinical Diagnostics | LOT NUMBER / EXPIRATION DATE : HBK133 12/17/2004 | Ortho-Clinical Diagnostics, Inc. has confirmed complaints of positive control failures when using ORTHO Antibody to HBsAg ELISA Test System 3. | Ortho Clinical Diagnostics |
| 8/16/2004 | Recall of Trima Accel LRS Tubing Sets-Gambro BCT, Inc | Catalog Numbers: LOT NUMBER / EXPIRATION DATE : | Gambro BCT recently began to receive an increased number of reports of significantly lower yields/concentrations on platelet products that were collected on the Trima Accel Automated Blood Collection System. | Gambro BCT, Inc. Lakewood, Colorado |
| 7/21/2004 | Recall of Amicus Separator Apheresis Device-Baxter Healthcare Corp | Amicus Separator apheresis device, product codes 4R4580 and 4R4580R, installed with software version 2.51 | Baxter Healthcare Corporation received four user reports that the Amicus Separator collected more plasma in the course of an apheresis procedure than desired or collected plasma when none was targeted. | Baxter Healthcare Corporation |
| 7/14/2004 | Recall of Limulus Amebocyte Lysate (LAL), Pyrotell-Associates of Cape Cod, Inc | LOT NUMBER / EXPIRATION DATE : | Internal testing by Associates of Cape Cod, Inc. discovered that one lot of Pyrotell (2mL/vial, Lot # 201-07-211) showed moisture content slightly above specification. | Associates of Cape Cod, Inc. |
| 6/24/2004 | Recall of Amplicor HIV-1 Monitor Test, v 1.5-Roche Molecular Systems, Inc | Amplicor [3] AV-HRP Avidin-HRP (Horseradish Peroxidase) BGG Conjugate, Lot No. E09569, found in kit Lot No. E11360, Material No. 21118560018, expiration January, 2005 Amplicor [3] AV-HRP Avidin-HRP (Horseradish Peroxidase)BGG Conjugate, Lot No. E09569, found in kit Lot No. E11231, Material No. 21117750123, expiration September, 2004 NOTE: This product was only distributed to foreign consignees. | Roche has confirmed increased frequency of occurrence of "blue foci" with the Avidin-Horseradish Peroxidase (AV-HRP) Conjugate Lot E09659. | Roche Molecular Systems, Inc |
| 6/24/2004 | Market Withdrawal of Immune Globulin Intravenous (Human), GAMMAGARD S/D, 10 gm-Baxter SA | LOT NUMBER / EXPIRATION DATE: LE08D030AA 3/30/2006 | There has been an increased frequency of adverse event reports of allergic reactions associated with this lot. | Baxter SA |
| 5/17/2004 | Recall of NucliSens Automated Isolation Reagents for Use with NucliSens HIV-1 QT - bioMerieux bv | LOT NUMBER: 04031904 | Some irregularities have been observed with one lot of this raw material, which may affect the sensitivity and accuracy of assays, such as the NucliSens HIV QT. | bioMerieux bv |
| 5/13/2004 | Medical Device Notification: HIV-1/HIV-2 Plus O EIA Testing Software-DiaSporin, Inc | HIV-1 / HIV-2 Plus O EIA Testing Software | An error was contained on the ETI-LAB Applications disk for programming the BioRad HIV-1/HIV-2 Plus O assay. | DiaSorin, Inc |
| 5/13/2004 | Recall of Ortho Assay Software (OAS) Version 2.0 (For Use with the Ortho Summit Sample Handling System)-Ortho Clinical Diagnostics, Inc | Ortho Assay Software; Version 2.0 | Ortho Clinical Diagnostics (OCD) has received reports that sample or reagent could be dispensed twice if an 'Error 137' is generated during the pipetting of a plate. | Ortho Clinical Diagnostics, Inc. |
| 4/23/2004 | Recall of MTS Anti-IgG Card and MTS A/B/D Monoclonal and Reverse Grouping Card-Micro Typing Systems, Inc | PRODUCT / LOT NUMBER / EXPIRATION DATE: MTS Anti-IgG Card / 082203001-14 / 7/15/2004 MTS A/B/D Monoclonal and Reverse Grouping Card / 111903037-11 / 10/23/2004 | Micro Typing Systems, Inc. (MTS) has received reports of gel not present in one microtube of a limited number of cards. | Micro Typing Systems, Inc |
| 4/2/2004 | Recall of Rabies Vaccine (Human Diploid Cell), Imovax Rabies-Aventis Pasteur | LOT NUMBER / EXPIRATION DATE : X0667-2 6/24/2006 | Aventis Pasteur is recalling four lots of Imovax Rabies, Rabies Vaccine (Human Diploid Cell) that were distributed in the U.S. This is a precautionary measure stemming from the discovery through routine testing of a non-inactivated production strain of virus in a single product lot, which was not distributed. | Aventis Pasteur |
| 4/2/2004 | Notice to Readers: Manufacturer's Recall of Human Rabies Vaccine-MMWR | LOT NUMBER / EXPIRATION DATE : X0667-2 6/24/2006 | These lots were produced during the same period as the lot that contained noninactivated Pitman-Moore virus. | Aventis Pasteur Swiftwater, PA |
| 4/1/2004 | Recall of Immune Globulin Intravenous (Human), Gammar-P I.V., 10 gm-Aventis Behring L.L.C. | LOT NUMBER / EXPIRATION DATE: A639110 10/23/2006 | These lots exhibit an increased frequency of non-serious, labeled adverse events associated with allergic reactions. | Aventis Behring L.L.C. |
| 3/12/2004 | Recall of Allergenic Extracts - Hollister-Stier Laboratories LLC | PRODUCT / LOT NUMBER / EXPIRATION DATE: Acacia Golden / A43C2180 7/1/2005 | Hollister-Stier is recalling these lots of allergenic extract because the expiration date printed on the clear overlay label may smear when exposed to moisture. | Hollister-Stier Laboratories LLC |
| 1/9/2004 | Recall of Blood Bank Data Management System Software - Information Data Management | IDM Surround System, Software versions 3.4, 3.5, and 3.6 | IDM's Surround System fails to recognize duplicate batches when used in conjunction with the Abbott PPC (Parallel Processing Center) and the TPC (Total Process Control) mode is utilized. | Information Data Management |
