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U.S. Department of Health and Human Services

Class 2 Device Recall BioPlex 2200

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  Class 2 Device Recall BioPlex 2200 see related information
Date Initiated by Firm November 13, 2007
Date Posted April 22, 2008
Recall Status1 Terminated 3 on July 23, 2008
Recall Number Z-0575-2008
Recall Event ID 45892
510(K)Number K043341  
Product Classification automated immunodiagnostic analyzer software - Product Code NVI
Product BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547

Code Information All software version 2.0, used with Calibrator Lots 86280 and 86290.
Recalling Firm/
Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact
Manufacturer Reason
for Recall
Incorrect values: An error was found in the BioPlex 2200 Software, Version 2.0 that results in assignment values being utilized for the BioPlex assay Calibrator Set that may be slightly different from those printed on the Value Assignment Data Sheet. Some values may be identical between the lot assignment combinations with the ANA Screen with MDSS kit.
FDA Determined
Cause 2
Software design
Action Bio-Rad sent a Voluntary Field Correction notice dated November 1, 2007. Consignees were notified by phone call on Nov. 13, 2007, followed up by facsimile (domestic). Sub-recall to be by e-mail message for consignees outside the US. Distribution of the product ceased on Nov. 2, 2007. Bio-Rad will provide Calibrator Set CDs with only one lot of calibrator assignment values until a new version of software is available.
Quantity in Commerce 85 units of calibrator lot 86280 and 16 units of calibrator lot 86290 were distributed.
Distribution Worldwide Distribution - USA, Canada, France, and Germany.
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 = NVI and Original Applicant = BIO-RAD LABORATORIES, INC.