BEUDAMED
    FDA Recall Terminated

    Hypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles.

    Recall: Z-0275-04 · Initiated November 26, 2003

    Recall

    Recall Number
    Z-0275-04
    Event Number
    27760
    Firm
    Hypoguard USA, Inc.
    FEI Number
    1832816
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 26, 2003
    Posted
    December 25, 2003
    Terminated
    November 21, 2005
    Address
    5182 W 76th St, Edina, MN, 55439-2900

    Description

    Hypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles.

    Reason

    When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings.

    Action

    The consignees were sent letters dated 11/26/03 which requested that the product be returned.

    Distribution

    The product was distributed to consignees located nationwide in the United States.

    Quantity

    10-count bottles 6336; 50-count bottles 73,490; and 100-count bottles 221