BEUDAMED
    FDA Recall Terminated

    Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R2. (Clinical chemistry)

    Recall: Z-0220-2009 · Initiated September 10, 2008

    Recall

    Recall Number
    Z-0220-2009
    Event Number
    49466
    Firm
    Pointe Scientific, Inc.
    FEI Number
    1827821
    Product Code
    CFR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 10, 2008
    Posted
    October 31, 2008
    Terminated
    November 27, 2009
    Address
    5449 Research Dr, Canton, MI, 48188

    Description

    Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R2. (Clinical chemistry)

    Reason

    The inability of the product to maintain stated performance specifications through the stated shelf life.

    Action

    Consignees are being notified by letter dated 9/10/08 which will be sent out via fax, email or certified mail to all direct account and drop-ship customers. Customers are advised to dispose of any recalled product found and to consider test results obtained with these lots questionable. Contact Pointe Scientific, Inc. at 1-800-757-5313 or 1-734-487-8300 for assistance.

    Distribution

    Nationwide, Canada, China, Romania and Trinidad.

    Quantity

    4