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U.S. Department of Health and Human Services

Class 2 Device Recall BioPlex 2200 EBV IgM on the BioPlex 2200 MultiAnalyte

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  Class 2 Device Recall BioPlex 2200 EBV IgM on the BioPlex 2200 MultiAnalyte see related information
Date Initiated by Firm November 13, 2007
Date Posted June 11, 2008
Recall Status1 Terminated 3 on May 23, 2011
Recall Number Z-1158-2008
Recall Event ID 45875
510(K)Number K062213  
Product Classification EBV IgM in-vitro diagnostic test kit - Product Code LSE
Product BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is a multiplex flow immunoassay intended for the qualitative detection of two (2) analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum.
Code Information Lot Numbers: 943712 Exp. 7/30/07 and 943713 Exp. 4/30/08     
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories
6565 185th Ave NE
Redmond WA 98052-5039
For Additional Information Contact Scott J. Dennis
425-498-1709
Manufacturer Reason
for Recall		 False negative results due to reagent packs exhibiting low signal.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 11/13/2007, the firm faxed Voluntary Field Correction Letters (which are dated 11/9/2007) to its consignees and also contacted them via telephone. The Voluntary Field Correction Letters: a) informed them of the potential for false negative results; b) recommended that they perform QC testing daily with each reagent pack; c) provided a new insert for the Instructions for Use; and d) provided a Response Sheet for each consignee to complete and return to the firm.
Quantity in Commerce 996 kits
Distribution Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LSE and Original Applicant = BIO-RAD LABORATORIES, INC.
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