BEUDAMED
    FDA Recall Terminated

    ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064

    Recall: Z-0513-06 · Initiated December 21, 2005

    Recall

    Recall Number
    Z-0513-06
    Event Number
    34297
    Firm
    Abbott Laboratories MPG
    FEI Number
    1415939
    Product Code
    MMI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 21, 2005
    Posted
    February 14, 2006
    Terminated
    July 31, 2006
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064

    Reason

    There has been an increase in customer complaints observed for failure to calibrate or inability to generate patient result errors.

    Action

    Abbott sent recall letters dated 12/20/05 to the laboratory accounts via Federal Express Priority on 12/21/05. The accounts were informed of the increase in customer complaints for failure to calibrate or inability to generate patient result errors for the Troponin-I Reagent lot, and were requested to discontinue use and destroy any of the affected lot found in inventory for replacement.

    Distribution

    Nationwide and internationally to Canada, Australia, Germany and Taiwan

    Quantity

    181 kits