BEUDAMED
    FDA Recall Terminated

    Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, England

    Recall: Z-0786-06 · Initiated February 14, 2006

    Recall

    Recall Number
    Z-0786-06
    Event Number
    34612
    Firm
    Remel, Inc.
    FEI Number
    1924669
    Product Code
    KTN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 14, 2006
    Posted
    April 22, 2006
    Terminated
    March 6, 2008
    Address
    12076 Santa Fe Trail Dr (PO Box 14478, zip 66285-4478), Lenexa, KS, 66215-3519

    Description

    Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, England

    Reason

    Some units exhibit weak false-positive reactions with some negative patient serum

    Action

    The recalling firm issued a letter dated 2/14/06 to their only customer requesting the product be destroyed. The distributor was audited by FDA to assure subrecall

    Distribution

    Nationwide-Distribution was made to a New Jersey distributor.

    Quantity

    27 units