Date Initiated by Firm | November 13, 2007 |
Date Posted | June 11, 2008 |
Recall Status1 |
Terminated 3 on May 23, 2011 |
Recall Number | Z-1157-2008 |
Recall Event ID |
45875 |
510(K)Number | K062211 |
Product Classification |
EBV IgG in-vitro diagnostic test kit - Product Code LSE
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Product | BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is multiflow immunoassay intended for the quantitative detection of IgG antibodies to three (3) seperate EBV antigens in human serum. They are: 1) Epstein-Barr Virus Nuclear Antigen-1 (EBV-NA-1); 2) Viral Capsid Antigen (EBV VCA); and 3) Early Antigen diffuse (EBV EA-D). |
Code Information |
Lot Numbers: 943710 Exp. 7/30/07 and 943711 Exp. 4/30/08 |
Recalling Firm/ Manufacturer |
Bio-Rad Laboratories 6565 185th Ave NE Redmond WA 98052-5039
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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 | 1,020 kits |
Distribution | Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LSE
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