BEUDAMED
    FDA Recall Terminated

    Elecsys Troponin T; catalog number 2017644

    Recall: Z-0870-03 · Initiated April 25, 2003

    Recall

    Recall Number
    Z-0870-03
    Event Number
    26091
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    MMI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 25, 2003
    Posted
    May 29, 2003
    Terminated
    June 19, 2003
    Address
    9115 Hague Road, Indianapolis, IN, 46250-0457

    Description

    Elecsys Troponin T; catalog number 2017644

    Reason

    Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.

    Action

    An Urgent Product Correction letter was mailed to each account, during the week of 4/21/03, advising them not to use hemolyzed specimens with a hemoglobin level equal to, or greater than, 0.1 g/dL.

    Distribution

    United States