BEUDAMED
    FDA Recall Terminated

    Liberty Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

    Recall: Z-0048-06 · Initiated June 7, 2005

    Recall

    Recall Number
    Z-0048-06
    Event Number
    33301
    Firm
    Abbott Laboratories Medisense Products
    FEI Number
    3002803444
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 7, 2005
    Posted
    October 21, 2005
    Terminated
    May 17, 2006
    Address
    1360 S Loop Rd, Alameda, CA, 94502-7000

    Description

    Liberty Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

    Reason

    User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

    Action

    The firm has undertaken a field correction to notify their customers of the potential for the units of measure to be changed. The firm plans to (1) include a flyer in all Precision Xtra and FreeStyle meter kits to reinforce current labeling regarding units of measure and update the Frequently Asked Questions section of the website to reinforce the units of measure change, (2) Lock out the units of measure in new production meters to eliminate potential to change the units of measure settings, update the meter kits with a flyer to override the section of the manual indicating that the units of measure are changeable, and change the product insert in glucose test strips to indicate which units of measure are appropriate for the user and (3) update the labeling to indicate that the units of measure are not user configurable to eliminate the need for the flier.

    Distribution

    Approximately 10,005,206 meters have been distributed worldwide since 1999, with 5,885,332 meters distributed in the US, and 4,517,211 in use.