FDA Device recall Z-1369-2015
ACCU-CHEK Connect Diabetes Management App
- FDA Device
- Class II
- terminated
- Published 2015-04-08
On 2015-04-08 the FDA classified a Class II recall of ACCU-CHEK Connect Diabetes Management App by Roche Diabetes Care, citing roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided to the us….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1369-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-30 |
| Published | 2015-04-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Diabetes Care |
| Distribution | n/a |
Product
ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
Reason
Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided to the user. A thorough investigation of the situation revealed that this issue may occur if the user changes the screen orientation of the phone from portrait to landscape or vise versa while looking at the Bolus Advisor or Carb
Identifiers
| code_info | N/A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 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-1369-2015%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.