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Terminated

Accu-Chek Connect Diabetes Management App

FDA Recall Z-2753-2019 · Posted None

Recalling FirmRoche Diabetes Care, Inc.
Recall StatusTerminated
Product CodeNDC
Date Initiated2019-05-03
Date Terminated2020-10-30

Reason for Recall

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

Firm 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.

Root Cause

Software in the Use Environment

Distribution Pattern

Nationwide and worldwide usage of the Connect App.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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