BEUDAMED
    FDA Recall Terminated

    ICON 25 hCG test kit.

    Recall: Z-0374-04 · Initiated December 22, 2003

    Recall

    Recall Number
    Z-0374-04
    Event Number
    28017
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    JHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 22, 2003
    Posted
    January 29, 2004
    Terminated
    May 24, 2004
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    ICON 25 hCG test kit.

    Reason

    Test can exhibit false negative results.

    Action

    Customer letter was sent 12/22/03 via US Mail. It instructs users to discontinue use of product for replacement.