RecallDepth

Accu-Chek Connect Diabetes Management App

Company
Roche Diabetes Care, Inc.
Recall Initiated
May 3, 2019
Terminated
October 30, 2020
Recall Number
Z-2753-2019
Firm Location
Indianapolis, IN

Reason for Recall

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

Distribution

Nationwide and worldwide usage of the Connect App.

Lot / Code Info

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

Root Cause

Software in the Use Environment

Action Taken

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.

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