BEUDAMED
    FDA Recall Terminated

    Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261, Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Meridian Diagnostics.

    Recall: Z-0613-2011 · Initiated February 24, 2010

    Recall

    Recall Number
    Z-0613-2011
    Event Number
    56386
    Firm
    Bio-Rad Laboratories Inc
    FEI Number
    2915274
    Product Code
    LKJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 24, 2010
    Posted
    December 13, 2010
    Terminated
    January 10, 2011
    Address
    4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

    Description

    Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261, Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Meridian Diagnostics.

    Reason

    False positive test results caused by decrease in the OD values of ANA Cutoff Controls and ANA Positive Controls. The increased positivity rates were associated with the Meridian ANA Screening kit. False positive ANA values could result in misdiagnosis or mistreatment .

    Action

    Bio-Rad issued an Urgent Medical Device Recall NOtification letter dated February 24, 2010 to their distributor, identifying the affected product and actions to be taken. The distributor was instructed to examine inventory and quarantive affected kit lots, and to identify and notify customers with affected lots to discontinue use and discard the product. Replacement kits will be distributed. Customers were asked to complete and return a recall response form. Bio-Rad can be contacted at 510 724-7000 concerning this recall.

    Distribution

    Nationwide Distribution: to Meridian Diagnostics in Ohio.