BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547
- Company
- Bio-Rad Laboratories Inc
- Recall Initiated
- November 13, 2007
- Posted
- April 22, 2008
- Terminated
- July 23, 2008
- Recall Number
- Z-0575-2008
- Quantity
- 85 units of calibrator lot 86280 and 16 units of calibrator lot 86290 were distributed.
- Firm Location
- Hercules, CA
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.
Distribution
Worldwide Distribution - USA, Canada, France, and Germany.
Lot / Code Info
All software version 2.0, used with Calibrator Lots 86280 and 86290.
Root Cause
Software design
Action Taken
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.