BEUDAMED
    FDA Recall Terminated

    Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---.

    Recall: Z-1001-2007 · Initiated June 6, 2007

    Recall

    Recall Number
    Z-1001-2007
    Event Number
    38118
    Firm
    Bayer Healthcare LLC
    FEI Number
    1826988
    Product Code
    LFR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 6, 2007
    Posted
    July 3, 2007
    Terminated
    November 30, 2007
    Address
    430 S Beiger Street, Mishawaka, IN, 46544-3207

    Description

    Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---.

    Reason

    Incorrect Unit of Measure displayed : The meters report results in the wrong unit of measurement for Canadian users.

    Action

    The firm began calling Canadian customers on or about 6/06/07 to inform them of the problem, to tell them that a meter with the correct measurement units will be sent to them, and to request that they return the meter currently in their possession.

    Distribution

    Canada.

    Quantity

    16-Canadian Units only are affected