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ACCU-CHEK CONNECTRecalls & reported problems across all models

Roche Diagnostics Operations, Inc. · 2 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls
2

We found 2 models of ACCU-CHEK CONNECT by Roche Diagnostics Operations, Inc. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Feb 3, 2020 and Apr 28, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (6 reports).

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ACCU-CHEK CONNECT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Dec 20, 2016Terminated

    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.

    Z-1099-2017 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

  2. Sep 14, 2016Terminated

    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.

    Z-0586-2017 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

Most reported ACCU-CHEK CONNECT problems

Device problems

  • Application Program Problem: Dose Calculation Error6

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • No Consequences Or Impact To Patient2
  • No Known Impact Or Consequence To Patient1

ACCU-CHEK CONNECT models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent ACCU-CHEK CONNECT adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Roche Diagnostics Operations, Inc. products

All Roche Diagnostics Operations, Inc. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page