BEUDAMED
    FDA Enforcement Class II Completed

    FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System

    Recall: Z-0734-2024 · Reported January 24, 2024

    Enforcement

    Recall Number
    Z-0734-2024
    Event ID
    93393
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Abbott Diabetes Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 24, 2024
    Initiation Date
    February 9, 2023
    Classification Date
    January 16, 2024
    Address
    1360 S Loop Rd, N/A, Alameda, CA, 94502-7000, United States

    Description

    FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System

    Reason

    If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.

    Code Info

    UDI-DI: 00357599816001, Software v.3.4.0 and below

    Distribution

    US Nationwide distribution in the states of NY, CA, NJ, UT, PA, MS, OH, TX, MN, FL, LA, NE, MI, VA, NC, MA, IN, SC, IA.

    Quantity

    45,173