Roche Recalls Accu-Chek Connect iOS App Version 1.2.0 Due to Software Bug
Roche Diabetes Care is recalling version 1.2.0 of the Accu-Chek Connect iOS app because a programming error in the Bolus Advisor feature could lead to incorrect insulin bolus recommendations.
What this means for you
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 involves a software defect in a medical device that could lead to incorrect insulin dosing, a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Roche Diabetes Care, Inc. has initiated a voluntary recall of version 1.2.0 of the Accu-Chek Connect Diabetes Management App for iOS. This specific version was released on July 11, 2016. The recall is due to a programming error, or bug, identified in the Bolus Advisor feature of the software.
The defect in the Bolus Advisor feature could lead to an incorrect insulin bolus recommendation. This poses a risk to users who rely on the app for insulin dosing guidance. The recall affects 7,909 downloads in the United States and 8,775 downloads internationally.
Users of version 1.2.0 of the Accu-Chek Connect app on iOS devices should stop using the Bolus Advisor feature immediately. They should consult their healthcare provider for insulin dosing instructions and check for updated versions of the app that may resolve the issue.
The recalled product
- Product
- Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
- Manufacturer
- Roche Diabetes Care, Inc.
- Category
- Medical Device — Software
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)
- 2016
- Catalog number 07562462001 / GTIN number 00365702700000
Distribution
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