BEUDAMED
    FDA Recall Terminated

    Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)

    Recall: Z-2400-2010 · Initiated April 13, 2010

    Recall

    Recall Number
    Z-2400-2010
    Event Number
    55610
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    MMI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 13, 2010
    Posted
    September 11, 2010
    Terminated
    October 25, 2010
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)

    Reason

    False elevated Stratus CS CTNI results

    Action

    Recalling firm issued " Urgent Field Safety Notice" dated April 2010, informing users of the problem and to discuss with laboratory directors regarding the need to review previous test results, conduct patient follow up, and/or repeat testing for tests conducted on or after Nov 1, 2009.

    Distribution

    Nationwide Distribution

    Quantity

    7500 cartons