BEUDAMED
    FDA Recall Terminated

    BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547

    Recall: Z-0575-2008 · Initiated November 13, 2007

    Recall

    Recall Number
    Z-0575-2008
    Event Number
    45892
    Firm
    Bio-Rad Laboratories Inc
    FEI Number
    2915274
    Product Code
    NVI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 13, 2007
    Posted
    April 22, 2008
    Terminated
    July 23, 2008
    Address
    4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

    Description

    BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547

    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.

    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.

    Distribution

    Worldwide Distribution - USA, Canada, France, and Germany.

    Quantity

    85 units of calibrator lot 86280 and 16 units of calibrator lot 86290 were distributed.