BEUDAMED
    FDA Recall Terminated

    ProSpecT Campylobacter Microplate Assay. Catalog #2476096.

    Recall: Z-1372-04 · Initiated July 15, 2002

    Recall

    Recall Number
    Z-1372-04
    Event Number
    29672
    Firm
    Remel, Inc.
    FEI Number
    1924669
    Product Code
    LQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 15, 2002
    Posted
    August 17, 2004
    Terminated
    December 28, 2006
    Address
    12076 Santa Fe Trail Dr (PO Box 14478, zip 66285-4478), Lenexa, KS, 66215-3519

    Description

    ProSpecT Campylobacter Microplate Assay. Catalog #2476096.

    Reason

    A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.

    Action

    Remel contacted the customer with a letter, requesting a count of the affected lot, and offered replacement of the kits.

    Distribution

    Entire lot was shipped to one customer in Russelsheim, Germany.

    Quantity

    382