BEUDAMED
    FDA Recall Terminated

    IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibrator along with other reagents; Abbott Laboratories, Abbott Park, IL

    Recall: Z-0681-03 · Initiated March 4, 2003

    Recall

    Recall Number
    Z-0681-03
    Event Number
    25690
    Firm
    Abbott Laboratories HPD/ADD
    FEI Number
    1415939
    Product Code
    MOI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 4, 2003
    Posted
    March 26, 2003
    Terminated
    September 15, 2004
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibrator along with other reagents; Abbott Laboratories, Abbott Park, IL

    Reason

    The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.

    Action

    Recalled by letter dated 3/4/03. The accounts were informed of the depressed values for the CA 15-3 High Control and for patient specimens, and were requested to discontinue use and destroy any of the three affected lots found in inventory.

    Distribution

    Nationwide and Ecuador, England, Hong Kong, Chile, Japan, Canada, Singapore, Australia, Pakistan, Argentina, Thailand, Aruba, Korea and Jamaica.

    Quantity

    409 packs