BEUDAMED
    FDA Recall Terminated

    Accu-Chek Connect Diabetes Management App

    Recall: Z-2753-2019 · Initiated May 3, 2019

    Recall

    Recall Number
    Z-2753-2019
    Event Number
    83566
    Firm
    Roche Diabetes Care, Inc.
    FEI Number
    3011393376
    Product Code
    NDC
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    May 3, 2019
    Terminated
    October 30, 2020
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    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.

    Action

    On 5/2/19, the firm notified affiliates of the issue via a Quality Notice. On 5/16/19, the firm issued an updated Quality Notice stating that a new version of the software, 2.1.7.2 would soon become available which would resolve the data transfer issues. Call centers were also provided with a workaround for customers who called in reporting an issue with transferring results. On 5/24/19, version 2.1.7.2 of the Connect App was released for Android on the Google Play store. This version of the app corrects the data transfer issue. At this time, users were notified via the "What's New" section of Google Play. These users were informed that the new version addresses issues with wireless data transfers from blood glucose meters. Customers with questions regarding this event should call the ACCU-CHEK Customer Care Software support line at 1-800-628-3346.

    Distribution

    Nationwide and worldwide usage of the Connect App.