BEUDAMED
    FDA Recall Terminated

    FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with FreeStyle Lite Blood Glucose Meters and FreeStyle Freedom Lite Blood Glucose Meters, Part Number 70822-02, manufactured by Abbott Diabetes Care, Inc., Alameda, CA. The product is used for testing outside the body (in vitro) diagnostic use, in the home and in professional settings to monitor blood glucose levels.

    Recall: Z-1936-2009 · Initiated June 10, 2009

    Recall

    Recall Number
    Z-1936-2009
    Event Number
    52427
    Firm
    Abbott Diabetes Care, Inc.
    FEI Number
    3002803444
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 10, 2009
    Posted
    September 1, 2009
    Terminated
    January 10, 2011
    Address
    1360 South Loop Road, Alameda, CA, 94502-7000

    Description

    FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with FreeStyle Lite Blood Glucose Meters and FreeStyle Freedom Lite Blood Glucose Meters, Part Number 70822-02, manufactured by Abbott Diabetes Care, Inc., Alameda, CA. The product is used for testing outside the body (in vitro) diagnostic use, in the home and in professional settings to monitor blood glucose levels.

    Reason

    Low results: Freestyle Lite Blood Glucose Test strip may generate low blood glucose readings when tested with the control solution from lot 0822524 with Freestyle Freedom Lite and Freestyle Lite Blood Glucose Meters.

    Action

    An "Important: Medical Device Notification" letter dated June 10, 2009 was issued to consignees. First consignees received notifications via letters to both direct consignees and registered customers of FreeStyle Lite and FreeStyle Freedom Lite blood glucose meter users in the states where the affected test strip lot was distributed. Affected accounts and customers were instructed to discontinue distribution and use of the product. The notification will be posted to the Abbott Diabetes Care website. Direct questions about the recall to Abbott Diabetes Care, Inc. by calling 510-749-5400.

    Distribution

    US only (states AL, AZ, CA, FL, GA, IL, IN, MD, NJ, NY, OH, PA, RI, SC, TN, TX and WI).

    Quantity

    9,252 vials