BEUDAMED
    FDA Enforcement Class II Terminated

    Accu-Chek Connect Diabetes Management App

    Recall: Z-2753-2019 · Reported October 2, 2019

    Enforcement

    Recall Number
    Z-2753-2019
    Event ID
    83566
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diabetes Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    October 2, 2019
    Initiation Date
    May 3, 2019
    Classification Date
    September 26, 2019
    Termination Date
    October 30, 2020
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025, United States

    Description

    Accu-Chek Connect Diabetes Management App

    Reason

    Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.

    Code Info

    Connect App version 2.1.6.3 when used with Android OS 8.0 and above.

    Distribution

    Nationwide and worldwide usage of the Connect App.