The Recall Desk
SevereFDA (Devices)·Z-1899-2017·Announced 2017-05-10

Roche Recalls Accu-Chek Connect App Due to Bolus Advisor Error

Roche Diabetes Care is recalling specific versions of the Accu-Chek Connect app because a bug in the Bolus Advisor feature may provide incorrect insulin dosing advice.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury (insulin over-delivery) due to incorrect medical device advice, which aligns with the 'Severe' criteria for significant injury reports or high-risk device defects.

Plain-English summary

Roche Diabetes Care, Inc. is recalling versions 2.0.0, 2.0.1, and 2.1.0 of the Accu-Chek Connect Diabetes Management App for iOS and Android. The recall is due to a program error in the Bolus Advisor feature that could result in incorrect bolus advice and a potential insulin over-delivery.

The affected digital product was available for download from the Apple App Store and the Google Play Store. The recall covers distribution in the United States, including specific states listed in the agency records, as well as users in the rest of the world excluding Canada. The total number of downloads is not available, but the source notes specific user counts for the last 30 days prior to March 23, 2017.

Consumers using these specific versions of the app should stop using the Bolus Advisor feature. Users should consult their healthcare provider for insulin dosing advice until the issue is resolved.

The recalled product

Product
Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available
Manufacturer
Roche Diabetes Care, Inc.
Category
Medical Device — Software
Hazard
Affected units
64,324

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 (2)

  • Accu-Chek Connect Diabetes Management App versions 2.0.0
  • 2.0.1 and 2.1.0 for iOS and Android

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

Related recalls

Same manufacturer · Roche Diabetes Care, Inc.

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Same hazard · incorrect dosing

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