Recall Z-0575-2008 ยท NVI Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
Bio-Rad Laboratories Inc
BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547
| Date | Apr 22, 2008 (initiated Nov 13, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 85 units of calibrator lot 86280 and 16 units of calibrator lot 86290 were distributed. |
| Distribution | Worldwide Distribution - USA, Canada, France, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043341 | BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM Bio-Rad Laboratories, Inc., Oct 27, 2005 |