BEUDAMED
    FDA Recall Terminated

    Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250.

    Recall: Z-1014-2010 · Initiated July 29, 2009

    Recall

    Recall Number
    Z-1014-2010
    Event Number
    52851
    Firm
    Pointe Scientific, Inc.
    FEI Number
    1827821
    Product Code
    CIG
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    July 29, 2009
    Posted
    March 5, 2010
    Terminated
    December 6, 2010
    Address
    5449 Research Dr, Canton, MI, 48188

    Description

    Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250.

    Reason

    R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and would not pass the required quality control (calibration and quality control testing) before beginning running the bilirubin assay.

    Action

    Consignee was notified by letter dated 7/29/2009 and instructed to identify and notify them at once of this product recall. Product is to be returned or destroyed. Customers with questions should contact the firm directly.

    Distribution

    California.

    Quantity

    2