Recall Z-2753-2019
Roche Diabetes Care, Inc. · initiated May 3, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Accu-Chek Connect Diabetes Management App
Codes / lots: Connect App version 2.1.6.3 when used with Android OS 8.0 and above.
Reason for recall
Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.
FDA-determined 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.
Details
- Recall number
- Z-2753-2019
- Initiated
- May 3, 2019
- Terminated
- October 30, 2020
- Product code
- NDC – Calculator, Drug Dose
- Distribution
- Nationwide and worldwide usage of the Connect App.
- Recalling firm
- Roche Diabetes Care, Inc., Indianapolis, IN