BEUDAMED
    FDA Recall Terminated

    LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037

    Recall: Z-0453-2007 · Initiated September 29, 2006

    Recall

    Recall Number
    Z-0453-2007
    Event Number
    36774
    Firm
    Lifescan Inc
    FEI Number
    2939301
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2006
    Posted
    January 5, 2007
    Terminated
    November 27, 2007
    Address
    1000 Gibraltar Dr, Milpitas, CA, 95035-6312

    Description

    LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037

    Reason

    Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.

    Action

    The firm has issued notification on 9/29/06 to consumers and hospital end users known to the firm and direct accounts that received the recalled product. The firm also posted the notice on the website, and customer service scripting was developed to notify callers.

    Distribution

    Nationwide to Al, AZ, CA, CN, DE, FL, GA, IL, IN, KT, KY, LA, MA, MD, MI, MN, MS, MO, NE, NJ, NM, and TX.

    Quantity

    26,398 units (both recall numbers Z-0452/3-2007