BEUDAMED
    FDA Recall Terminated

    FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.

    Recall: Z-1245-2013 · Initiated April 15, 2013

    Recall

    Recall Number
    Z-1245-2013
    Event Number
    64876
    Firm
    Abbott Diabetes Care, Inc.
    FEI Number
    3002803444
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 15, 2013
    Posted
    May 9, 2013
    Terminated
    August 3, 2015
    Address
    1360 S Loop Rd, Alameda, CA, 94502-7000

    Description

    FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.

    Reason

    AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.

    Action

    Abbott Diabetes Care sent an Urgent Product Recall letter dated April 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take one of the following options immediately to address the issue. 1) Customers can access a software update to resolve the issue at www.freestyleinsulinx.com/swupdate. 2) Customers can contact Abbott Diabetes Care Customers Service at 1-866-723-2697 to expedite return and replacement of the affected product at no charge. For questions customers were instructed to call Abbott Diabetes Care Customers Service at 1-866-723-2697. For questions regarding this recall call 510-239-2775.

    Distribution

    Nationwide Distribution

    Quantity

    335,273 meters; 209,336 remain at firm.