BEUDAMED
    FDA Recall Terminated

    Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials

    Recall: Z-0773-04 · Initiated March 1, 2004

    Recall

    Recall Number
    Z-0773-04
    Event Number
    28607
    Firm
    Dade Behring Inc. Rte 896, Glasgow Business Community
    FEI Number
    2517506
    Product Code
    GFO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 1, 2004
    Posted
    July 20, 2004
    Terminated
    August 19, 2004
    Address
    Newark, DE, 19702

    Description

    Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials

    Reason

    cloudy appearance or precipitate

    Action

    The recalling firm issued recall letters dated 3/4/04 to their direct accounts informing them of the problem and what to do if a vial is found to be cloudy.

    Distribution

    The products were shipped to one diagnostic facility in PA. The products were also shipped to Germany, Poland, Spain, France, Italy, Portugal, Mexico, Thailand, and Uruguay.

    Quantity

    77886 vials