BEUDAMED
    FDA Recall Terminated

    LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037.

    Recall: Z-1317-2008 · Initiated December 18, 2007

    Recall

    Recall Number
    Z-1317-2008
    Event Number
    46398
    Firm
    Lifescan Inc
    FEI Number
    2939301
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 18, 2007
    Posted
    April 8, 2008
    Terminated
    July 18, 2008
    Address
    1000 Gibraltar Dr, Milpitas, CA, 95035-6312

    Description

    LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037.

    Reason

    Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.

    Action

    The firm sent an Urgent Recall letter to Health Care Professionals on 12/18/2007. The letter advised user to uninstall software drivers and provided options on how to uninstall. For further assistance, please contact LifeScan Customer Service at 1-866-679-9250.

    Distribution

    Nationwide Distribution including the states of AL, CA, IN, IO, MA, MD, MI, MS, NE, NY, NC, OR, PA, TN, TX, UT, VT, VA, WV, and WI.

    Quantity

    260 units