BEUDAMED
    FDA Recall Terminated

    Lifescan OneTouch SureStep Meter Blood Glucose monitoring system,Product is distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037

    Recall: Z-0101-06 · Initiated September 9, 2005

    Recall

    Recall Number
    Z-0101-06
    Event Number
    33121
    Firm
    Lifescan Inc
    FEI Number
    2939301
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 9, 2005
    Posted
    October 28, 2005
    Terminated
    December 18, 2006
    Address
    1000 Gibraltar Dr, Milpitas, CA, 95035-6301

    Description

    Lifescan OneTouch SureStep Meter Blood Glucose monitoring system,Product is distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037

    Reason

    The LCD of the OneTouch SureStep Meter may display incorrectly, resulting in missing segments on the display. This display failure may result in patients misreading the blood glucose result, or cause a delay in test interpretation, and could cause delays or mistreatment.

    Action

    On 9/9/05, ***and 4/14/06 (expanded)***the firm notified its consumers, Health Care Professionals (HCPs), pharmacies, and direct accounts (including wholesalers and distributors) by letter and phone calls.

    Distribution

    Total amount of product distributed in the U.S. is 19,177 units, to distribution centers to be distributed to retailers, Health Care Professionals, wholesalers, and mail order companies. The product was distributed throughout the United States; 29,377 were distributed to Asia, Europe and Latin America.

    Quantity

    19,177 meters were distributed in the U.S., with 29,377 distributed abroad, to Asia, Europe and Latin America.