BEUDAMED
    FDA Recall Terminated

    StreamLab Analytical Workcell. General Purpose Laboratory Device.

    Recall: Z-0373-05 · Initiated November 12, 2004

    Recall

    Recall Number
    Z-0373-05
    Event Number
    30518
    Firm
    Dade Behring Inc. Rte 896, Glasgow Business Community
    FEI Number
    2517506
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 12, 2004
    Posted
    December 28, 2004
    Terminated
    March 28, 2005
    Address
    Newark, DE, 19702

    Description

    StreamLab Analytical Workcell. General Purpose Laboratory Device.

    Reason

    Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems.

    Action

    The recalling firm issued letters dated 11/12/04 to their customers informing them of the problem. The letter also states that a sales representative will contact them to make arrangements for an upgrade.

    Distribution

    The product was shipped to hospitals in IL, MD, NJ, OH, and VA. The product was also shipped to Italy, Spain, and Portugal.

    Quantity

    15 units