Roche Recalls Accu-Chek Connect App Due to Insulin Dosing Errors
Roche Diabetes Care is recalling the Accu-Chek Connect app because software defects may cause incorrect insulin bolus recommendations, potentially leading to hypoglycemia.
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 the source text explicitly states that incorrect bolus advice could lead to serious health consequences such as hypoglycemia, meeting the criteria for a Severe rating.
Plain-English summary
Roche Diabetes Care, Inc. is recalling the Accu-Chek Connect Diabetes Management App for iOS and Android. The recall is due to software defects that may cause the app to disregard historical bolus data or fail to offer a correction bolus recommendation within the eligible time window following a blood glucose measurement. These issues may result in incorrect bolus insulin recommendations being provided to users.
The affected app versions are distributed directly to end users via the Apple App Store and the Google Play App Store. The recall covers 27,243 units. The software issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect.
Depending on the individual's metabolic situation, potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Users should not use the app to manually calculate a bolus. Consumers should stop using the affected app versions and follow instructions from the manufacturer or healthcare provider.
The recalled product
- Product
- Accu-Chek Connect Diabetes Management App
- Manufacturer
- Roche Diabetes Care, Inc.
- Affected units
- 27,243
Distribution
Distributed nationwide across the United States.
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