Z-0575-2008

BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad...

Name: Z-0575-2008 BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad...
Creator: Bio-Rad Laboratories Inc
Published: 2007-11-13
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2007-11-13 / Terminated / root cause: software

FDA source

Bio-Rad Laboratories Inc began a recall of BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547 on 2007-11-13. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0575-2008
Status: Terminated
Initiated: 2007-11-13
Posted: 2008-04-22
Terminated: 2008-07-23
Recalling firm: Bio-Rad Laboratories Inc.
Product: BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547
Product code: NVI Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
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.
Root cause tag: software
FDA 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 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.
Product codes and lots: All software version 2.0, used with Calibrator Lots 86280 and 86290.

Product code NVI

K043341Class IIBioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories, Inc. / cleared 2005-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)