BEUDAMED
    FDA Recall Terminated

    DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.

    Recall: Z-0042-05 · Initiated August 27, 2004

    Recall

    Recall Number
    Z-0042-05
    Event Number
    30005
    Firm
    Dade Behring Inc. Rte 896, Glasgow Business Community
    FEI Number
    2517506
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 27, 2004
    Posted
    October 23, 2004
    Terminated
    May 10, 2005
    Address
    Newark, DE, 19702

    Description

    DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.

    Reason

    APTT determinations when using affected rotors may lead to incorrectly shortened times

    Action

    The recalling firm issued a recall letter dated 8/27/04 to their direct accounts informing them of the problem. The recalling firm also sent instructions for a work around until a solution can be established.

    Distribution

    The product was shipped to medical facilities nationwide. The product was shipped to one government facility in TN.

    Quantity

    7140 units