Agency classClass IIOur severity:High FDA (Devices)·Z-1369-2015·Announced 2015-04-08

Roche Recalls Accu-Chek Connect App Due to Inaccurate Bolus Advice

Roche Diabetes Care is recalling the Accu-Chek Connect app because a screen orientation change may cause it to provide inaccurate bolus advice to users.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk-of-harm product (inaccurate insulin dosing) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Roche Diabetes Care, Inc. is recalling the ACCU-CHEK Connect Diabetes Management App and its Instruction Manual. The recall is due to a software issue that could potentially lead to the app providing inaccurate bolus advice to the user. The problem may occur if a user changes the phone's screen orientation from portrait to landscape, or vice versa, while viewing the Bolus Advisor or Carb features.

The affected device is not marketed in the United States, and there are no US distributors. The application was distributed in Germany, Italy, and South Africa. According to the source, the application has been downloaded a total of 644 times, with 401 downloads in Germany, 219 in Italy, and 24 in South Africa. There have been 113 bolus advice activations.

Users in the affected regions should stop using the application for bolus advice until further notice. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
Manufacturer: Roche Diabetes Care, Inc.
Category: Medical Device — Diabetes Management Software
Hazard: inaccurate-dosing
software-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Roche Diabetes Care, Inc.

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Same hazard · inaccurate dosing