BEUDAMED
    FDA Recall Terminated

    ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Park, IL 60064 U.S.A.

    Recall: Z-0781-04 · Initiated March 23, 2004

    Recall

    Recall Number
    Z-0781-04
    Event Number
    28641
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    NIG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 23, 2004
    Posted
    July 20, 2004
    Terminated
    April 26, 2005
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Park, IL 60064 U.S.A.

    Reason

    The reagent lots may produce patient results that are lower than expected when compared to other lots of in-date reagents.

    Action

    Abbott international affiliates were notified of the recall by e-mail on 3/23/04, and requested to notify their customers.

    Distribution

    Canada, Australia, Germany and Japan

    Quantity

    1,987 kits