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.
The bug in the software can change the unit of measurement within the app unexpectedly, according to Roche. The company told its Accu-Chek users in June last year to update the app to version 2.1.1 and clear the data collected from the Accu-check blood glucose meter before pairing with the updated app for the first time.
Roche added that after updating its diabetes management app, people using the Bolus Advisor feature should carefully monitor their active insulin and insulin bolus amounts for at least eight hours.
There are more than 67,000 people using version 2.1.0 of Roche’s Accu-Chek app, according to the company.
