Roche Diabetes Care, Inc. recalls ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.

Recall date

October 30, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1369-2015

FDA classification

Class II

Brand / firm

Roche Diabetes Care, Inc.

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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