FDA Device recall Z-0197-2018
Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / G…
- FDA Device
- Class II
- terminated
- Published 2017-12-13
On 2017-12-13 the FDA classified a Class II recall of Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / G… by Roche Diabetes Care, citing certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0197-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-08 |
| Published | 2017-12-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diabetes Care |
| Distribution | US |
Product
Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. The Accu-Chek Bolus Advisor, as a component of the Accu-Chek Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data
Reason
Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter the rare condition in which the countdown timer is not displayed and correction bolus advice is not available for the most recent, valid glucose reading. This same blood glucose value may become available for bolus advice calculation at a later time (countdown timer is displayed).
Identifiers
| code_info | Software Versions 1.0.5, 1.0.15, 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, 2.1.0, and 2.1.1 for iOS and Android. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Roche Diabetes Care
- Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm…
FDA Device · Class II · 2024-07-03 · Roche Diabetes Care - RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001
FDA Device · Class II · 2022-05-04 · Roche Diabetes Care - Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care - Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care - Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care
All Roche Diabetes Care recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0197-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.