BEUDAMED
    FDA Recall Terminated

    Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.

    Recall: Z-0172-06 · Initiated July 29, 2005

    Recall

    Recall Number
    Z-0172-06
    Event Number
    32887
    Firm
    Dade Behring Inc.
    FEI Number
    2517506
    Product Code
    DAP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 29, 2005
    Posted
    November 18, 2005
    Terminated
    March 1, 2006
    Address
    500 GBC Dr. PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.

    Reason

    Reports of false negative results on Sysmex Coagulation System.

    Action

    On 7/29/05, the recalling firm issued a recall letter to their accounts informing them of the probelm. The letter also provided instruction on how to prevent the probelm from occurring - change from the AKIMA method to the Point ot Point method.

    Distribution

    The product was shipped to medical facilities nationwide.

    Quantity

    2987 units