BEUDAMED
    FDA Recall Terminated

    Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured by Bio-Rad, Hercules, CA

    Recall: Z-0539-2011 · Initiated March 1, 2010

    Recall

    Recall Number
    Z-0539-2011
    Event Number
    56047
    Firm
    Bio-Rad Laboratories Inc
    FEI Number
    2915274
    Product Code
    LKJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 1, 2010
    Posted
    December 6, 2010
    Terminated
    January 5, 2011
    Address
    4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

    Description

    Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured by Bio-Rad, Hercules, CA

    Reason

    The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.

    Action

    Bio-Rad issued an Urgent Medical Device Recall Notification letter dated March 1, 2010 to customers describing the issue and actions to be taken. Responses will be tracked via response forms. The letter instructed customers that affected products should be identified, quarantined, and discarded, or reworked with shorter expiration dates until newer lots are available. Bio-Rad can be contacted at 510-724-7000 concerning this recall.

    Distribution

    Worldwide Distribution: Throughout the US, and to the countries of: Australia, Canada, France, Hong Kong, India, Italy, Japan, New Zealand, Panama, Singapore, South Korea and the UK.