Roche Diabetes Care, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0197-2018)

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 software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. The Accu-Chek Bolus Advisor, as a component of the Accu-Chek Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data

Product Classification:

Class II

Date Initiated: June 8, 2017

Date Posted: December 13, 2017

Recall Number: Z-0197-2018

Event ID: 77635

Reason for Recall:

Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter the rare condition in which the countdown timer is not displayed and correction bolus advice is not available for the most recent, valid glucose reading. This same blood glucose value may become available for bolus advice calculation at a later time (countdown timer is displayed).

Status: Terminated

Product Quantity: 1,134 bolus advisor features used

Code Information:

Software Versions 1.0.5, 1.0.15, 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, 2.1.0, and 2.1.1 for iOS and Android.

Distribution Pattern:

Worldwide Distribution - US (Nationwide) and Canada

Voluntary or Mandated:

Voluntary: Firm initiated