Vaccines, Blood & Biologics
2007 Biologics Recalls
| Date Notification | Brand Name | Product Description | Reason/Problem | Company |
|---|---|---|---|---|
| 12/24/2007 | Market Withdrawal of Octagam-Octapharma USA Inc. | Octagam [Immune Globulin Intravenous (Human) 5%] Lot Number: A732B8431 Expiration Date: August 2009 | Octapharma is taking this voluntary action based on several reports related to non life-threatening allergic type skin reactions in connection with this lot. | Octapharma USA Inc. Vienna, Austria |
| 12/14/2007 | Medical Device Notification: Sunquest Laboratory Blood Bank Module - Sunquest Information Systems, Inc | Sunquest Laboratory Blood Bank Module v6.0.1 and v6.0.2 Distributed with Sunquest Laboratory v6.1, v6.2 and v6.3 | The system does not trigger all Quality Assurance warnings/failures when there is a mismatch between the reaction results and the interpretation. | Sunquest Information Systems, Inc. |
| 12/11/2007 | Recall of PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] and COMVAX [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine]-Merck & Co., Inc. | PRODUCT DESCRIPTION/LOT#/EXP. DATE PedvaxHIB®/0677U 11/January 2010 PedvaxHIB®/0820U 12/January 2010 PedvaxHIB®/0995U 16/January 2010 PedvaxHIB®/1164U 18/January 2010 PedvaxHIB®/0259U 17/October 2009 PedvaxHIB®/0435U 18/October 2009 PedvaxHIB®/0436U 19/October 2009 PedvaxHIB®/0437U 19/October 2009 PedvaxHIB®/0819U 09/January 2010 PedvaxHIB®/1167U 10/January 2010 PedvaxHIB®/J2438 24/October 2009 COMVAX®/0376U 05/January 2010 COMVAX®/0377U 08/January 2010 | These lots of PedvaxHIB and COMVAX are being recalled due to lack of assurance of product sterility. | Merck & Co., Inc. West Point, PA |
| 11/26/2007 | Recall of Tubing Sets used with COBE Spectra Apheresis System, Trima and Trima Accel Automated Blood Collection Systems-Gambro BCT, Inc. | COBE Spectra Disposable Tubing Sets Catalog Number/Tubing Set Name/Lot Number 000777110/Dual-Needle Extended Life Platelet Set with LRS Chamber/03N0005;04NXXXXX; 05NXXXXX; 06NXXXXX; 07N15247 70100/Dual-Needle Extended Life Platelet Set/04NXXXXX; 05NXXXXX; 07N15244 70300/Dual-Needle Extended Life Platelet Set with LRS Chamber/03N0006; 04NXXXXX; 05NXXXXX; 06NXXXXX; 07N15246 70310/Dual-Needle Extended Life Platelet Set with LRS Chamber/04NXXXXX; 05NXXXXX; 06NXXXXX; 70400/Single-Needle Extended Life Platelet Set with LRS Chamber/04NXXXXX; 05NXXXXX; 07N15228 777003005/Dual- Needle Extended Life Platelet Set/04NXXXXX; 05NXXXXX 777003015/Dual-Needle Extended Life Platelet Set with LRS Chamber/03N15290; 04NXXXXX; 05NXXXXX; 06NXXXXX; 07N15245; 07N15306 777003215/Single-Needle Extended Life Platelet Set with LRS Chamber/03N15288; 03N15289; 04NXXXXX; 05NXXXXX; 06NXXXXX; 07N15216
Trima Automated Blood Collection Disposable Tubing Sets | Gambro BCT is receiving a number of reports of a leak occurring near the spike port on the secondary platelet collect bag on COBE Spectra and Trima tubing sets. The secondary platelet bag does not have the Platelet Product Sampler (sample bulb). | Gambro BCT, Inc. Lakewood, CO |
| 10/30/2007 | Important Notification: Blood Grouping Reagent Anti-Lea BioClone 2.0-Ortho Clinical Diagnotics, Inc. | Blood Grouping Reagent Anti Lea BioClone 2.0 Product Code 715280 Lot Number/Product Code 6901859 Lot Number/ Expiration Date
LAB129A/LAB129AX/3/10/2008 | OCD has received complaints of weakened reactivity or false negative reactions when using the referenced lots. | Ortho Clinical Diagnostics, Inc. (OCD) Raritan, New Jersey |
| 10/29/2007 | Recall of CROFAB (Crotalidae Polyvalent Immune Fab (Ovine)-Protherics | CROFAB - Crotalidae Polyvalent Immune FAB (Ovine) / 200623 / May 2008 | The recall of CroFab has been initiated due to sub-potency of this lot of product at the 24 month stability point. | Protherics Wales, United Kingdom |
| 9/19/2007 | Medical Device Notification: Data Innovations Instrument Manager-Data Innovations, Inc. | Data Innovations Instrument Manager - Software versions 7.04.0001 through 8.04.03.01 | Corrupt database indices in the Specimen Management database could cause the misassociation of test and test result for a specific specimen(s). | Data Innovations, Inc. South Burlington, Vermont |
| 8/1/2007 | Medical Device Notification: TERUFLEX CPDA-1 Blood Bag System-Terumo Medical Corporation | TERUFLEX Blood Bags with Blood Sampling Arm CPDA-1 Anticoagulant 450 mL Collection Bag; Triple Blood Bag
PRODUCT CODE: 1BB*TCD456A4 | Terumo has initiated a voluntary removal of the TERUFLEX CPDA-1 Blood Bag System because of a noted labeling discrepancy with this product. | Terumo Medical Corporation |
| 7/24/2007 | Field Correction of Transfer Sets Packed with Humate-P - CSL Behring LLC | Transfer sets packed together with Humate-P (STN# 103960) | CSL Behring has identified that blisters of the blue transfer set, which is provided with Humate-P (STN #103960) may have small holes and the transfer set should not be used anymore. | CSL Behring LLC King of Prussia, PA |
| 7/23/2007 | Recall of Level 1 Normothermic IV Fluid Administration and Irrigation Sets-Smiths Medical ASD, Inc. | REF Codes: D-50, D-60HL, D-70, D-100, D-300, IR-40, IR-500, IR-600, IR-700 All products with an expiration date on or before July 2011 | Smiths Medical has become aware that some heat exchangers in the sets may have a leakage of the inner lumen which may allow the heating fluid to enter the patient fluid path or vice versa, which can cause contamination of the blood or solutions being infused or the recirculating solution. | Smiths Medical ASD, Inc. Rockland, MA |
| 7/21/2007 | Recall of CS3000 Apheresis Kits-Fenwal, Inc. | CS 3000 Apheresis Kits (All lot numbers starting with "N") Product Codes: 4R2180T, 4R2210T International Distribution: R4R2210T, R4R2230T | Fenwal has become aware of two instances where the anticoagulant citrate dextrose (ACD) and saline lines were reversed in the assembly process. | Fenwal, Inc. Round Lake, IL |
| 6/12/2007 | Recall of m2000sp and m1000 Instrument-TECAN Schweiz AG / Abbott Molecular, Inc. | m2000sp Instrument and m1000 Instrument List Numbers 9K14-01 and 4J72-01 Not Serial Number Specific) | Abbott has recently identified that spring clips on the Disposable Tips (DiTi) Racks, shipped with or ordered independent of m2000sp or m1000 Instruments, may have sharp protruding corners. | TECAN Schweiz AG Switzerland |
| 4/13/2007 | Recall of Bean, String Green Allergenic Extract-Alk Abello | Bean, String Green Allergenic Extract, Vial (5) Lot Number: 5L01102 | Recent tests show that the pH of the product lot exceeded the lower specification limit of pH 6.3. | Alk Abello Port Washington, New York |
| 3/9/2007 | Market Withdrawal of LAL Reagent - Associate of Cape Cod | Pyrotell Multitest Catalog Number: G2006 Lot Number: 206-09-395 Expiration Date: 07 Sep 2011 Catalog Number: G5006 Lot Number: 506-09-396 Expiration Date; 11 Sep 2011 | This product was released with a labeled sensitivity of 0.06 EU/mL. Some samples recently tested from this lot have shown a change in sensitivity. | Associate of Cape Cod East Falmouth, MA |
| 3/5/2007 | Recall of Medical Devices - Biomet Biologics, Inc | 800-0503A/GPS Mini Platelet Concentrate Separation Kit with 30mL ACD-A 800-0504A/GPS Mini Platelet Concentrate Separation Kit with 50ML ACD-A 800-0515/Plasmax Plus Plasma Concentrator with GPS II and 50ML ACD-A 800-1001A/GPS II Platelet Concentrate Separation Kit 50mL ACD-A 800-1002A/GPS II Platelet Concentrate Separation Kit 50mL ACD-A Double 800-0501/Plasma Plasma Concentrator with GPS Mini and 50mL ACD-A International Distribution Only: 800-0621A/GPS II Double Unit with Syringes 30mL ACD-A 800-0650/Recover Mini Platelet Separation Kit 30mL ACD-A 800-0721A/GPS II Single Unit with Syringes 30mL ACD-A 800-0921/GPS II Single Unit with Syringes | This action was initiated due to the unit label on a limited number of syringes was incorrect, citing 20mL size. | Biomet Biologics, Inc. Warsaw, Indiana |
| 2/22/2007 | Important Notification: Fast Flow Fluid Warmers-Smiths Medical | Level 1 H-1200 with H-30 and/or H-31B Fast Flow Fluid Warmer Users Level 1 H-30, H-31A and/or H-31B Air Detector Clamp Users | The Quick Reference Guides include an additional warning that the Air Detector/Clamp is deactivated with the unit is turned off, when power is otherwise lost to the device. | Smiths Medical Rockland, MA |
| 2/21/2007 | Biological Product Withdrawal of Carimune NF Immune Globulin Intravenous-ZLB Behring | Carimune® NF Immune Globulin Intravenous Lot Number: 43017-0016 Expiration: 11/26/2009 | During routine inspection of undistributed lots, ZLB identified vials with glass particles. | ZLB Behring Bern, Switzerland |
| 1/9/2007 | Recall of FETALSCREEN - Ortho-Clinical Diagnostics | FETALSCREEN Product Code 780540 Lot FS472 (expiration date: January 16, 2007) Lot FS473 (expiration date: February 13, 2007) | Ortho-Clinical Diagnostics has received reports of weak or negative reactivity with the positive control provided in FETALSCREEN lots FS472 and FS473. | Ortho-Clinical Diagnostics Raritan, New Jersey |
