BEUDAMED
    FDA Recall Terminated

    AxSYM Folate Specimen Diluent, list 3C81-50, 10 mL bottles containing TRIS buffer with protein stabilizer; Abbott Laboratories, Abbott Park, IL 60064 USA

    Recall: Z-0365-04 · Initiated December 16, 2003

    Recall

    Recall Number
    Z-0365-04
    Event Number
    27978
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    CGN--
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 16, 2003
    Posted
    July 20, 2004
    Terminated
    July 20, 2004
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    AxSYM Folate Specimen Diluent, list 3C81-50, 10 mL bottles containing TRIS buffer with protein stabilizer; Abbott Laboratories, Abbott Park, IL 60064 USA

    Reason

    The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

    Action

    Abbott notified their international affiliates via e-mail on 12/16/03 and 1/5/04. Device recall letters dated 12/16/03 and 12/31/03 will be sent to the end users by the affiliates, informing them of the unapproved serum albumin used to manufacture the folate products, and listing the impact to performance for each affected components. There are separate customer recall letters for each assay platform -- ARCHITECT, AxSYM and IMx.

    Distribution

    There was no U.S. distribution. The products were shipped internationally through Abbott affiliates in Canada, Germany, Singapore, Hong Kong, Australia, Brazil, New Zealand, Columbia, Chile, Uruguay, United Kingdom, Venezuela, Dominican Republic, Argentina and Curacao.

    Quantity

    375 kits