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U.S. Department of Health and Human Services

Class 2 Device Recall BioPlex 2200 Syphilis lgG on the BioPlex 2200 MultiAnalyte

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  Class 2 Device Recall BioPlex 2200 Syphilis lgG 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-1156-2008
Recall Event ID 45875
510(K)Number K063866  
Product Classification Syphilis IgG in-vitro diagnostic test kit - Product Code LIP
Product BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidium IgG antibodies in human serum.
Code Information Lot Numbers: 946314 Exp. 10/31/07, 950630 Exp. 1/31/08 and 946899 Exp. 2/28/08.       
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 796 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 = LIP and Original Applicant = Bio-Rad Laboratories
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