BEUDAMED
    FDA Recall Terminated

    ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496.

    Recall: Z-1374-04 · Initiated November 21, 2002

    Recall

    Recall Number
    Z-1374-04
    Event Number
    29679
    Firm
    Remel, Inc.
    FEI Number
    1924669
    Product Code
    MHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 21, 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 Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496.

    Reason

    The conjugate of the ProSpecT Giardia/Cryptosporidium Microplate Assay, Lot #926230, may have become contaminated during filling. The particulates in the contamination may cause the dropper tips to become plugged. Quality control testing indicated that the reagents were still performing as intended, including the conjugates.

    Action

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

    Distribution

    US only

    Quantity

    12