BEUDAMED
    FDA Enforcement Class II Terminated

    Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2

    Recall: Z-0260-2020 · Reported November 6, 2019

    Enforcement

    Recall Number
    Z-0260-2020
    Event ID
    83761
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LABSTYLE INNOVATIONS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    November 6, 2019
    Initiation Date
    August 29, 2019
    Classification Date
    October 31, 2019
    Termination Date
    May 5, 2020
    Address
    7, Derekh Menakhem Begin, Ramat Gan, N/A, Israel

    Description

    Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2

    Reason

    The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading.

    Code Info

    Android App Software versions 4.3.0-4.3.2

    Distribution

    Nationwide domestic distribution. Foreign distribution to Australia, Canada, UK, and Italy.

    Quantity

    126,271 (83,141 US; 43,130 OUS)