FDA issues warning for Roche ’ s Accu-Chek diabetes management app

The FDA today issued a Class 2 device recall for Roche‘s (OTC:RHHBY) Accu-Chek connected diabetes management app. The company first notified the regulatory agency of the software bug in June last year.
Roche reported that certain iOS and Andriod versions of the app had a program error in the Bolus Advisor feature – a calculator that helps the user determine insulin doses based on data from a glucose meter.
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Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Patient Monitoring Pharmaceuticals Recalls Wall Street Beat Roche Source Type: news