Roche Diabetes Care, Inc. Accu-Chek Connect Diabetes Management App Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Accu-Chek Connect Diabetes Management App
Brand
Roche Diabetes Care, Inc.
Lot Codes / Batch Numbers
Connect App version 2.1.6.3 when used with Android OS 8.0 and above.
Products Sold
Connect App version 2.1.6.3 when used with Android OS 8.0 and above.
Roche Diabetes Care, Inc. is recalling Accu-Chek Connect Diabetes Management App due to Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026