Recall Z-0625-2018 ยท NDC Calculator, Drug Dose
Roche Diabetes Care, Inc.
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
| Date | Jun 8, 2017 |
| Status | Terminated |
| Reason | Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpectedly change. This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice. |
| Root cause | Other |
| Action | On 06/13/2017, Roche Diabetes Care, Inc. made the Urgent Medical Device Correction notice available to their customers through the Accu-Chek.com website and through the Accu-Chek Connect microsite. Patients are instructed to: Update to version 2.1.1 of the Accu-Chek Connect app Clear all data from the Accu-Chek blood glucose meter following the steps below, before pairing with the Accu-Chek Connect app for the first time. This clearing of the records in the memory can be accomplished on the PC or Mac by using Accu-Chek Connect Device Link. A micro-USB cable and an Accu-Chek Connect Online acc |
| Quantity | 67,040 unique users of version 2.1.0 |
| Distribution | US Nationwide |
| 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 |