Food, drugs, devices › Roche Diabetes Care, Inc.
Device recall: Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
Roche Diabetes Care, Inc. (Indianapolis, IN) initiated this device recall on 14 Sep 2016; FDA lists 1 product record under event 75241, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 6 Jun 2017. Initiation: voluntary: firm initiated. Roche Diabetes Care, Inc. has 15 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Roche Diabetes Care, Inc., Indianapolis, IN.
Reason for recall
"Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming error (bug) in the Bolus Advisor feature, which could lead to an incorrect insulin bolus recommendation."
Distribution
"US Distribution to the states of : Alabama, Arizona, Arkansas, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0586-2017 | Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016 | 7,909 downloads of iOS version 1.2.0 of the Accu-Chek Connect Diabetes Management App in the US and 8,775 downloads… | Class II | Terminated | 23 Nov 2016 |
Context
Other enforcement events for Roche Diabetes Care, Inc.
All 15 events for Roche Diabetes Care, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming error (bug) in the Bolus Advisor feature, which could lead to an incorrect insulin bolus recommendation."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution to the states of : Alabama, Arizona, Arkansas, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Jun 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.