BEUDAMED
    FDA Recall Terminated

    Abbott brand FreeStyle Flash Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky. Alameda, CA 94502. Manufactured by: Flextronics International, Long Jing Industrial Estate, Long Jing Road, Xi Li Town, Nantou District, Shenzhen, China

    Recall: Z-1307-06 · Initiated May 22, 2006

    Recall

    Recall Number
    Z-1307-06
    Event Number
    35486
    Firm
    Abbott Diabetes Care, Inc.
    FEI Number
    3002803444
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 22, 2006
    Posted
    August 3, 2006
    Terminated
    December 21, 2006
    Address
    1360 S Loop Rd, Alameda, CA, 94502-7000

    Description

    Abbott brand FreeStyle Flash Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky. Alameda, CA 94502. Manufactured by: Flextronics International, Long Jing Industrial Estate, Long Jing Road, Xi Li Town, Nantou District, Shenzhen, China

    Reason

    The products may encounter display problem, 'Er 4' message, during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid user configuration data including selectable unit of measure, and strip calibration code.

    Action

    On 5/22/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions for the corrective actions.

    Distribution

    Worldwide

    Quantity

    2,365,000 meters (approx.-both types