BEUDAMED
    FDA Recall Terminated

    CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u/mL, B - 15 U/mL, C - 60 U/mL, D - 120 U/mL, E - 180 U/mL and F - 250 U/mL; Abbott Laboratories, Abbott Park, IL 60064

    Recall: Z-0680-03 · Initiated March 4, 2003

    Recall

    Recall Number
    Z-0680-03
    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

    CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u/mL, B - 15 U/mL, C - 60 U/mL, D - 120 U/mL, E - 180 U/mL and F - 250 U/mL; Abbott Laboratories, Abbott Park, IL 60064

    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

    792 packs