BEUDAMED
    FDA Recall Terminated

    OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose Meters, in 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico Medical device for quantitative measurement of glucose in whole blood for use in hospital and clinical settings. The product is also for use in quantitative measurement of glucose in venous, capillary, arterial and neonatal whole blood samples. This system can also be used by lay users at home.

    Recall: Z-2028-2010 · Initiated February 24, 2010

    Recall

    Recall Number
    Z-2028-2010
    Event Number
    54565
    Firm
    Lifescan Inc
    FEI Number
    2939301
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 24, 2010
    Posted
    July 17, 2010
    Terminated
    December 8, 2010
    Address
    1000 Gibraltar Dr, Milpitas, CA, 95035

    Description

    OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose Meters, in 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico Medical device for quantitative measurement of glucose in whole blood for use in hospital and clinical settings. The product is also for use in quantitative measurement of glucose in venous, capillary, arterial and neonatal whole blood samples. This system can also be used by lay users at home.

    Reason

    Products may provide inaccurate results at readings over 400 mg/dL

    Action

    The firm, Lifescan, Inc., issued two "Urgent Medical Device Recall" letters dated February 24, 2010 to all customers for the OneTouch SureStep Test Strips and the SureStep Pro Test Strips. The letters describes the product, problem and action to be taken by the customers. The customers were instructed to look at your test strip vials for the recalled lots and check the strips or if you have test strips from the lot, call LifeScan Customer Service at 800-574-6139 between 5 a.m. to 7 p.m. Pacific Time, seven days a week or visit www.SureStep.com. Replacement product will be shipped to you immediately at no charge. The customers were instructed to continue to test your blood glucose, while wafting for replacement. Also, the customers are asked to continue use of the meter with precautions if results over 400 units are observed. For more information, please visit www.SureStep.com or call our Healthcare Professional Line at 888-455-5627.

    Distribution

    Worldwide distribution: USA and countries of Europe, Latin America and Asia.

    Quantity

    8,626,350