BEUDAMED
    FDA Recall Terminated

    The Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.

    Recall: Z-0460-2011 · Initiated April 12, 2010

    Recall

    Recall Number
    Z-0460-2011
    Event Number
    55604
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    MMI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 12, 2010
    Posted
    November 24, 2010
    Terminated
    March 19, 2013
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    The Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.

    Reason

    Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate test results.

    Action

    Siemens issued an "Urgent Field Safety Notice" dated April 2010, informing users of the problem and instructing them to inspect cartridges for leaking fluid. Cartridges with leaking fluid should be reported to the Siemens Technical Solutions Center. The Technical Solutions Center can be contacted at 800 441 9250.

    Distribution

    Worldwide Distribution: USA, Europe, Australia, China, Japan, Korea, and Saudi Arabia.

    Quantity

    4966