BEUDAMED
    FDA Recall Terminated

    Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.

    Recall: Z-0538-05 · Initiated December 3, 2004

    Recall

    Recall Number
    Z-0538-05
    Event Number
    30634
    Firm
    Dade Behring Inc. Rte 896, Glasgow Business Community
    FEI Number
    2517506
    Product Code
    DAP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 3, 2004
    Posted
    February 15, 2005
    Terminated
    October 18, 2005
    Address
    Newark, DE, 19702

    Description

    Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.

    Reason

    decrease in product stability after reconstitution and reduced stability on board certain instrument systems

    Action

    The recalling firm issued a recall letter to their customers informing them of the problem and the need to use internal quality controls with the analyzers. The letter instructed customer to discard lot # 544545 and reduce the stability for the other lot numbers involved.

    Distribution

    The product was shipped nationwide to medical facilities.

    Quantity

    25381 units