BEUDAMED
    FDA Recall Terminated

    Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)

    Recall: Z-0007-06 · Initiated August 31, 2005

    Recall

    Recall Number
    Z-0007-06
    Event Number
    33412
    Firm
    Nichols Institute Diagnostics
    FEI Number
    2050095
    Product Code
    DHA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 31, 2005
    Posted
    October 6, 2005
    Terminated
    March 16, 2012
    Address
    1311 Calle Batido, San Clemente, CA, 92673-6316

    Description

    Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)

    Reason

    Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.

    Action

    Withdrawal letter was sent 08/30/2005 which request customers to stop using the product immediately and discard any remaining materials. A response card was included.

    Distribution

    Nationwide and China, Germany, & Australia

    Quantity

    174