BEUDAMED
    FDA Recall Terminated

    ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096.

    Recall: Z-1376-04 · Initiated May 9, 2002

    Recall

    Recall Number
    Z-1376-04
    Event Number
    29681
    Firm
    Remel, Inc.
    FEI Number
    1924669
    Product Code
    MHJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 9, 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 Cryptosporidium Microplate Assay. Catalog #2454096.

    Reason

    A potential stability problem has been identified with the Positive Controls in the referenced kit lots of the ProSpecT Cryptosporidium Microplate Assay. The Positive Control may NOT perform as intended through its expiration date and may invalidate an otherwise acceptable run. Quality control testing indicates the other reagents in these kits are performing as intended.

    Action

    A potential stability problem has been identified with the positive control in the ProSpecT CryptoSporidium Microplate Assay. The positive control may not perform as intended through its expiration date and may invalidate an otherwise acceptable run.

    Distribution

    in the US

    Quantity

    388 kits (187 - 910717, 201 - 912101)