BEUDAMED
    FDA Recall Terminated

    ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxins (STX1 & STX 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures.

    Recall: Z-1373-04 · Initiated July 18, 2002

    Recall

    Recall Number
    Z-1373-04
    Event Number
    29677
    Firm
    Remel, Inc.
    FEI Number
    1924669
    Product Code
    GMZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 18, 2002
    Posted
    August 17, 2004
    Terminated
    September 15, 2004
    Address
    12076 Santa Fe Trail Dr (PO Box 14478, zip 66285-4478), Lenexa, KS, 66215-3519

    Description

    ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxins (STX1 & STX 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures.

    Reason

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

    Action

    Remel contacted each customer with a letter, by mail, requesting a count of the affected lots to be returned. Product would be replaced upon customer request.

    Distribution

    US and OUS.

    Quantity

    83 (15-2474048, 68-2474096)