BEUDAMED
    FDA Recall Terminated

    Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc.

    Recall: Z-0612-2011 · Initiated June 24, 2010

    Recall

    Recall Number
    Z-0612-2011
    Event Number
    56126
    Firm
    Bio-Rad Laboratories Inc
    FEI Number
    2915274
    Product Code
    LKJ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 24, 2010
    Posted
    December 13, 2010
    Terminated
    August 8, 2011
    Address
    4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

    Description

    Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc.

    Reason

    Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not pass..

    Action

    Bio-Rad issued Medical Device Recall Notification letters dated June 24, 2010 to consignees, identifying the affected products and requested that all affected product be disposed of in accordance with local procedures. Response forms are to be completed and returned to the firm. Bio-Rad can be contacted for replacement product and about this recall at 510 741-6114.

    Distribution

    Nationwide Distribution: including the states of California, Ohio, Massachusetts, and Missouri. Product delivered to 11 consignees only in the US.

    Quantity

    37 units