BEUDAMED
    FDA Recall Terminated

    AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064

    Recall: Z-0782-04 · Initiated March 26, 2004

    Recall

    Recall Number
    Z-0782-04
    Event Number
    28649
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    MMI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 26, 2004
    Posted
    July 20, 2004
    Terminated
    October 14, 2004
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064

    Reason

    An increase in complaints of higher than normal patient results, some from the healthy population range to above the diagnostic cutoff for an Acute Myocardial Infarction.

    Action

    Recalled by telephone calls on 3/26/04 and a follow-up letter dated 3/25/04. The accounts were informed of the elevated patient results for the Troponin-I Reagent lots, and were requested to discontinue use and destroy any of the four affected lots found in inventory.

    Distribution

    Nationwide and internationally to Abbott affiliates in Argentina, Canada, Germany, Singapore, Hong Kong, Taiwan, Australia, New Zealand, Thailand, China and Korea.

    Quantity

    7,394 kits