Recall Z-0586-2017 ยท NDC Calculator, Drug Dose
Roche Diabetes Care, Inc.
Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
| Date | Nov 16, 2016 (initiated Sep 14, 2016) |
| Status | Terminated |
| Reason | Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming error (bug) in the Bolus Advisor feature, which could lead to an incorrect insulin bolus recommendation. |
| Root cause | Software design (manufacturing process) |
| Action | Roche Diabetes Care, Inc., initiated a voluntary recall on September 14, 2016, of the version 1.2.0 of the Accu-Chek Connect app on iOS products (iPhone, iPad). The Prescription Activation Service (PAS) which allows the users to activate the bolus advice feature was placed on product hold immediately. This measure prevented any new bolus advice activations. An updated version (V 1.2.2) of the Accu-Chek Connect Diabetes Management App for iOS that contains the fix for the issue was released on August 29, 2016. Patients were instructed to: If you use the Accu-Chek Connect App on an IOS prod |
| Quantity | 7,909 downloads of iOS version 1.2.0 of the Accu-Chek Connect Diabetes Management App in the US and 8,775 downloads Inte |
| Distribution | US Distribution to the states of : Alabama, Arizona, Arkansas, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, |
| 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 |