BEUDAMED
    FDA Recall Terminated

    Clinical Chemistry Uric Acid; LN 7D76-20

    Recall: Z-0769-04 · Initiated March 18, 2004

    Recall

    Recall Number
    Z-0769-04
    Event Number
    28627
    Firm
    Abbott Laboratories Diagnostic Div
    FEI Number
    2018433
    Product Code
    CDO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 18, 2004
    Posted
    July 20, 2004
    Terminated
    February 10, 2012
    Address
    820 Mission St, South Pasadena, CA, 91030-3142

    Description

    Clinical Chemistry Uric Acid; LN 7D76-20

    Reason

    Unacceptable upward drift of results in control runs within 24 hour period.

    Action

    Firm sent recall letters 3/18/2004 suggesting destruction and/or running QC tests every eight hours instead of every 24 hours as is in labeling.

    Distribution

    Nationwide and Mexico, Equador, Puerto Rico, Hong Kong, Bahamas, Venezuela, Argentina, Canada, New Zealand, Columbia, Brazil, England, Trinidad.

    Quantity

    796 kits.