Roche Diabetes Care, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0625-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017

Product Classification:

Class II

Date Initiated: June 8, 2017

Date Posted: February 21, 2018

Recall Number: Z-0625-2018

Event ID: 79001

Reason for Recall:

Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpectedly change. This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice.

Status: Terminated

Product Quantity: 67,040 unique users of version 2.1.0

Code Information:

Software Versions: 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, and 2.1.0

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated