BEUDAMED
    FDA Recall Terminated

    AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA

    Recall: Z-1218-03 · Initiated August 22, 2003

    Recall

    Recall Number
    Z-1218-03
    Event Number
    27069
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    LPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 22, 2003
    Posted
    September 11, 2003
    Terminated
    July 20, 2004
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA

    Reason

    There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others.

    Action

    Recall letters dated 8/22/03 informed users of the kit to kit difference within the lots, and outlined the actions needed to take for patient results obtained from the use of the affected kits. The customers were requested to destroy any remaining inventory of the affected reagents. Any questions were directed to Abbott's Customer Service at 1-877-422-2688.

    Distribution

    Lot 01724M300 was distributed nationwide, as well as to Canada, Singapore, Tahiland, Korea, Hong Kong and China. Lots 03314HN00 and 03533HN00 were distributed by Abbott's Delkenheim, Germany subsidiary worldwide outside of the United States. These two lots were not distributed in the U.S.

    Quantity

    3505 kits