BEUDAMED
    FDA Recall Terminated

    Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E

    Recall: Z-1040-05 · Initiated June 21, 2005

    Recall

    Recall Number
    Z-1040-05
    Event Number
    32537
    Firm
    Dade Behring Inc.
    FEI Number
    2517506
    Product Code
    GHH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 21, 2005
    Posted
    July 22, 2005
    Terminated
    May 1, 2006
    Address
    500 GBC Dr. PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E

    Reason

    positive control shows weak agglutination reaction

    Action

    The recalling firm notified their customers on 6/21/05 via letter dated 6/17/05. The customers were instructed to discontinue the use of the affected lot and discard any remaining inventory.

    Distribution

    The product was shipped to hospital laboratories nationwide. The product was also shipped to Hungary, Switzerland, Poland, Spain, Italy, Argentina, Columbia, Mexico, Panama, Phillipines, El Salvadore, and Taiwan.

    Quantity

    364 kits