BEUDAMED
    FDA Enforcement Class I Terminated

    All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch¿ VerioIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch¿ VerioIQ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

    Recall: Z-1074-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1074-2013
    Event ID
    64624
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Lifescan Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    March 11, 2013
    Classification Date
    April 12, 2013
    Termination Date
    August 3, 2015
    Address
    1000 Gibraltar Dr, N/A, Milpitas, CA, 95035-6301, United States

    Description

    All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch¿ VerioIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch¿ VerioIQ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

    Reason

    The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE.

    Code Info

    Part numbers: Verio IQ Systems Kits: 022 267-01, 022 267-01, 022 267-03; Verio IQ Starter Kits: 022 268 01, 022 268-02; Verio IQ Warranty Kits: 022 275 01, 022 275 02. All lots and serial numbers

    Distribution

    USA Nationwide Distribution

    Quantity

    US 710,413