BEUDAMED
    FDA Recall Terminated

    Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, inbuffered calf serum at the following concentrations: A - 0, B - 15, C - 50, D - 100, E - 200 and F - 350; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott park, IL 60064

    Recall: Z-0726-03 · Initiated March 4, 2003

    Recall

    Recall Number
    Z-0726-03
    Event Number
    25689
    Firm
    Abbott Laboratories HPD/ADD
    FEI Number
    1415939
    Product Code
    LOJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 4, 2003
    Posted
    April 16, 2003
    Terminated
    September 4, 2003
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, inbuffered calf serum at the following concentrations: A - 0, B - 15, C - 50, D - 100, E - 200 and F - 350; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott park, IL 60064

    Reason

    The IMx AFP Calibrators may cause depressed values for the IMx AFP Low Control, and cause patient results to be 20% lower than actual values

    Action

    Recalled by letter dated 3/4/03. The laboratory accounts were informed of the lot of calibrators causing depressed values for the IMx AFP Low Control, requested to destroy any of the suspect lot of calibrators, and recalibrate the AFP assay using a different lot of calibrators.

    Distribution

    Nationwide

    Quantity

    107 kits