Company: BioRad BioPlex 2200 Software
Date of Enforcement Report 4/23/2008
Class:ll

PRODUCT
BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Recall # Z-0575-2008

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.

RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc., Hercules, CA, by letter dated November 1, 2007, by telephone on November 13, 2007, followed up by facsimile and e-mail. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
85 units of calibrator lot 86280 and 16 units of calibrator lot 86290.

DISTRIBUTION
Nationwide, Canada, France, and Germany