BEUDAMED
    FDA Recall Terminated

    Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU782-246 and HU982-615. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.

    Recall: Z-0912-2010 · Initiated December 1, 2009

    Recall

    Recall Number
    Z-0912-2010
    Event Number
    54112
    Firm
    Pointe Scientific, Inc.
    FEI Number
    1827821
    Product Code
    KNK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 1, 2009
    Posted
    March 2, 2010
    Terminated
    October 8, 2010
    Address
    5449 Research Dr, Canton, MI, 48188

    Description

    Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU782-246 and HU982-615. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.

    Reason

    A process deviation occurred during the production of the R1 component which may affect its performance.

    Action

    Pointe Scientific, Inc. issued an "Urgent: Medical Device Recall" notification dated December 1, 2009. Consignees were instructed to examine their inventory for the affected product and discard the affected product immediately. For further information, contact Pointe Scientific, Inc. Technical Support at 1-800-757-5313 or 1-734-487-8300.

    Distribution

    Worldwide Distribution -- United States (California, Florida, Kentucky, Michigan, Ohio, Oklahoma and Virginia), Chile and Malaysia.

    Quantity

    12 kits