Roche Diabetes Care, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1099-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Accu-Chek Connect Diabetes Management App

Product Classification:

Class II

Date Initiated: December 20, 2016

Date Posted: February 1, 2017

Recall Number: Z-1099-2017

Event ID: 76147

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.

Status: Terminated

Product Quantity: 27243

Code Information:

Catalog number 07562462001 / GTIN number 00365702700000 Catalog number 07250452001 / GTIN number 00365702700017

Distribution Pattern:

Worldwide Distribution - Nationwide Distribution The Accu-Chek Connect App for iOS is distributed directly to end users via the Apple App Store. The Accu-Chek Connect App for Android is distributed directly to end users via the Google Play App Store.

Voluntary or Mandated:

Voluntary: Firm initiated