Roche Diabetes Care, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1369-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.

Product Classification:

Class II

Date Initiated: October 30, 2014

Date Posted: April 8, 2015

Recall Number: Z-1369-2015

Event ID: 70775

Reason for Recall:

Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided to the user. A thorough investigation of the situation revealed that this issue may occur if the user changes the screen orientation of the phone from portrait to landscape or vise versa while looking at the Bolus Advisor or Carb

Status: Terminated

Product Quantity: The application has been downloaded total of 644 times (Italy-219, South Africa-24, Germany-401) and there are 113 bolus advice activations.

Code Information:

N/A

Distribution Pattern:

There are no US distributors as the affected device is not marketed in the US. The affected device was distributed in Germany, Italy and South Africa. The application has been downloaded total of 644 times (Italy-219, South Africa-24, Germany-401) and there are 113 bolus advice activations.

Voluntary or Mandated:

Voluntary: Firm initiated