Reported Apr 8, 2015 · Terminated

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

Roche Diabetes Care, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Roche Diabetes Care, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025

Is this the product you have?

  • ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
Lot codes and dates
  • N/A
Amount recalled
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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 8, 2015 · Data as of Sep 19, 6:47 PM UTC

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