Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Accu-Chek Connect Diabetes Management App Recalled by Roche Diabetes Care, Inc. Due to iOS and Android: Under certain conditions the affected...

Date: December 20, 2016
Company: Roche Diabetes Care, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Roche Diabetes Care, Inc. directly.

Affected Products

Accu-Chek Connect Diabetes Management App

Quantity: 27243

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Roche Diabetes Care, Inc.

Roche Diabetes Care, Inc. has 29 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report