CLASS II Device recall · Reported 8 Apr 2015 · FDA Enforcement Report

Accu-chek Connect Diabetes Management App recalled

Roche Diabetes Care is recalling Accu-chek Connect Diabetes Management App. The recall was initiated on 30 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesN/A

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

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1369-2015
FDA event ID: 70775
Recalling firm: Roche Diabetes Care, Indianapolis, IN
Classification: Class II
Status: Terminated
Recall initiated: 30 Oct 2014
FDA classified: 2 Apr 2015
Reported: 8 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Medical Software

Timeline

30 Oct 2014	Recall initiated by company
2 Apr 2015	Classified by FDA	+154 days
8 Apr 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was 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.

Questions about this recall

Why was it recalled?

Which lots are affected?

N/A

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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