BEUDAMED
    FDA Recall Terminated

    Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 610 ml, Catalog no. HA926-610, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188

    Recall: Z-1114-2008 · Initiated December 14, 2007

    Recall

    Recall Number
    Z-1114-2008
    Event Number
    45909
    Firm
    Pointe Scientific, Inc.
    FEI Number
    1827821
    Product Code
    CKA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 14, 2007
    Posted
    May 22, 2008
    Terminated
    September 15, 2008
    Address
    5449 Research Dr, Canton, MI, 48188

    Description

    Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 610 ml, Catalog no. HA926-610, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188

    Reason

    Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.

    Action

    Pointe Scientific notified consignees via Urgent Medical Device Recall letters dated 12/14/07, instructed to dispose of the product and to send back a reply form to request replacement product.

    Distribution

    Worldwide Distribution - USA, Bolivia, Canada, Chile, China, Cyprus, Greece, Indonesia, Israel, Korea, Mexico, Pakistan, Panama, Peru, Philippines, Republic of Yemen, Russia, South Africa, Trinidad, Ukraine and West Indies.

    Quantity

    955 for all products.