Recall Z-2753-2019 ยท NDC Calculator, Drug Dose
Roche Diabetes Care, Inc.
Accu-Chek Connect Diabetes Management App
| Date | May 3, 2019 |
| Status | Terminated |
| Reason | Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App. |
| Root cause | Software in the Use Environment |
| 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 o |
| Distribution | Nationwide and worldwide usage of the Connect App. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150910 | ACCU-CHEK Connect Diabetes Management App Roche Diabetes Care, Inc., Jun 3, 2015 |