Accu-Chek Connect Diabetes Management App versions 2 — Class II medical device recall Z-1899-2017
Terminated recall by Roche Diabetes Care, Inc., reported 2017-05-10, distributed nationwide. A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potenti
| Recall number | Z-1899-2017 |
|---|---|
| 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 | 2017-03-14 |
| Classified | 2017-05-01 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2018-01-16 |
| Distributed | Nationwide (US) |
| Quantity | 64,324 |
Product
Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each affected version from the date of initial distribution through 03/23/2017 is noted in 7a. However, some users will have used all three affected versions as they upgraded from version to version when the versions became available and many others will have tried the app and discontinued use. In the last 30 days, 02/22/2017 03/23/2017, there have been 16,781 unique users in the US with 264 of those seeking bolus advice and 19,268 unique users in the rest of world (excluding Canada) with 415 of those users seeking bolus advice.
Reason for recall
A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery.
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-1899-2017. 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.