BEUDAMED
    FDA Recall Terminated

    Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.

    Recall: Z-0668-2009 · Initiated June 23, 2008

    Recall

    Recall Number
    Z-0668-2009
    Event Number
    49711
    Firm
    Dade Behring, Inc.
    FEI Number
    2517506
    Product Code
    JHX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 23, 2008
    Posted
    January 28, 2009
    Terminated
    January 29, 2009
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.

    Reason

    Incorrect result: Potential for false elevation of CTnI results

    Action

    Siemens issued an Urgent Field Safety Notice dated 6/23/08 with instructions to immediately discontinue use and discard the affected lots. Customers were also instructed to contact Siemens Customer Service Center at 800-241-0420 to request replacement product at no charge.

    Distribution

    Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India.

    Quantity

    5868 cartons