BEUDAMED
    FDA Recall Terminated

    Pointe Scientific Liquid Glucose (HEXO) Reagent Set, for the quantitative determination of glucose in serum, 10 x 100 ml R1, 10 x 20 ml R2 glucose reagent, or 1 x 2 L R1 x 500 ml R2, for use with Hitachi analyzer; in vitro diagnostic, Catalog numbers HG920-1200 and HG920-2500.

    Recall: Z-1329-06 · Initiated June 7, 2006

    Recall

    Recall Number
    Z-1329-06
    Event Number
    35498
    Firm
    Pointe Scientific, Inc.
    FEI Number
    1827821
    Product Code
    CFR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 7, 2006
    Posted
    August 3, 2006
    Terminated
    November 19, 2007
    Address
    5449 Research Dr, Canton, MI, 48188-2261

    Description

    Pointe Scientific Liquid Glucose (HEXO) Reagent Set, for the quantitative determination of glucose in serum, 10 x 100 ml R1, 10 x 20 ml R2 glucose reagent, or 1 x 2 L R1 x 500 ml R2, for use with Hitachi analyzer; in vitro diagnostic, Catalog numbers HG920-1200 and HG920-2500.

    Reason

    Product does not meet performance specifications through its labeled expiration period.

    Action

    Customers were notified via recall letter dated 6/7/06 to cease using and to discard these lots, and to send back the recall response form for replacement stocks.

    Distribution

    Worldwide, including USA, Canada, China, Panama, Russia and Trinidad.

    Quantity

    153 kits