BEUDAMED
    FDA Recall Terminated

    LifeScan OneTouch Ultra Test strips, lot number 2528640

    Recall: Z-0435-06 · Initiated November 1, 2005

    Recall

    Recall Number
    Z-0435-06
    Event Number
    34272
    Firm
    Lifescan Inc
    FEI Number
    2939301
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 1, 2005
    Posted
    January 24, 2006
    Terminated
    July 26, 2006
    Address
    1000 Gibraltar Dr, Milpitas, CA, 95035-6301

    Description

    LifeScan OneTouch Ultra Test strips, lot number 2528640

    Reason

    Product may be defective and may give low inaccurate glucose results.

    Action

    Recall was initiated in early November. Notifications were sent on November 21, 2005. The firm has also posted recall notices on its website, and Customer Service Scripting will be available to address questions from callers.

    Distribution

    7 direct consignees (2 wholesale dealers and 5 distributors_ located in CA, PA, IL, WI, MN, SD, OK, CN, MA, MI.

    Quantity

    7321 boxes of 100 count test strips (29338 vials)