BEUDAMED
    FDA Recall Terminated

    EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.

    Recall: Z-1174-2007 · Initiated July 3, 2007

    Recall

    Recall Number
    Z-1174-2007
    Event Number
    38384
    Firm
    Dade Behring, Inc.
    FEI Number
    2517506
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 3, 2007
    Posted
    August 22, 2007
    Terminated
    November 7, 2007
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.

    Reason

    Sample ID and Patient results could be associated with the wrong patient

    Action

    The recalling firm issued a Field Corrective Action letter dated 7/3/07 to inform their customers of the problem and that a software patch would be sent for them to download. The recalling firm plans to telephone the customers after the patch has been released to verify that it has been installed.

    Distribution

    Worldwide: USA including states of AZ, CA, FL, IL, MA. MI, MO, NC, OH, PA, TX, and WV. The product was also shipped to other Dade facilities in MO, DE, IL, CT, and Belgium.

    Quantity

    72 units