Accu-Chek Connect Diabetes Management App — Class II medical device recall Z-1099-2017
Terminated recall by Roche Diabetes Care, Inc., reported 2017-02-01, distributed nationwide. iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potent
| Recall number | Z-1099-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diabetes Care, Inc., Indianapolis, IN, United States |
| Recall initiated | 2016-12-20 |
| Classified | 2017-01-26 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2017-09-05 |
| Distributed | Nationwide (US) |
| Quantity | 27,243 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00365702700000, 00365702700017 |
| Model numbers | 07250452001, 07562462001 |
Product
Accu-Chek Connect Diabetes Management App
Reason for recall
iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and using multiple meters with the Accu-Chek Connect app can under rare circumstances cause the bolus advisor to fail to offer a correction bolus recommendation within the eligible time window following a blood glucose measurement (10 15 minutes). Depending on the individual metabolic situation potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Both software issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect and should not be used to manually calculate a bolus.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1099-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.