Recall Z-0575-2008
Bio-Rad Laboratories Inc · initiated November 13, 2007
Product
BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547
Codes / lots: All software version 2.0, used with Calibrator Lots 86280 and 86290.
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: 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.
Details
- Recall number
- Z-0575-2008
- Initiated
- November 13, 2007
- Posted by FDA
- April 22, 2008
- Terminated
- July 23, 2008
- Product code
- NVI – Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
- Quantity
- 85 units of calibrator lot 86280 and 16 units of calibrator lot 86290 were distributed.
- Distribution
- Worldwide Distribution - USA, Canada, France, and Germany.
- Recalling firm
- Bio-Rad Laboratories Inc, Hercules, CA