BEUDAMED
    FDA Recall Terminated

    ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591

    Recall: Z-0580-2008 · Initiated June 7, 2007

    Recall

    Recall Number
    Z-0580-2008
    Event Number
    44725
    Firm
    Siemens Medical Solutions Diagnostics
    FEI Number
    2432235
    Product Code
    MMI
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    June 7, 2007
    Posted
    June 5, 2008
    Terminated
    August 28, 2012
    Address
    511 Benedict Avenue, Tarrytown, NY, 10591-5005

    Description

    ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591

    Reason

    Incorrect results: Falsely elevated Troponin values have been reported which are inconsistent with the patient's clinical picture and test negative by other Troponin assays.

    Action

    Two Support Bulletins (078N0361-01 & 078N0361-02) were sent by e-mail to all affected Siemens Diagnostics Branches to inform them of this issue. The first one was sent on 6/07/07 and the second one was sent on 7/05/07. Two Customer Bulletins (078D0647-01 & 078D0651-01) were sent by e-mail to the Siemens Diagnostics Branches for communication with the affected customers. The first one was sent on 6/07/07 and the second one was sent on 7/05/07. These bulletins state that if a false positive is suspected, the sample should be diluted and retested.

    Distribution

    Worldwide Distribution - USA, Argentina, Austria, Australia, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Malaysia, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela

    Quantity

    Domestic: 31,497 kits; Foreign: 27,321 kits