The FDA labeled a recall of the Insulet
(NYSE: PODD)
Omnipod 5 App for Android smartphones as Class I, the most serious kind.
Insulet’s recall — a correction, not a product removal — affects software versions 1.1-1.2.3 for the Omnipod 5 automated insulin delivery system. It distributed the software between April 20, 2023, and Dec. 20, 2023. The company initiated the recall, which affects 28,919 devices in the U.S., on Nov. 7, 2023.
The Omnipod 5 App uses SmartAdjust technology to help adjust insulin delivery based on real-time and future blood sugar levels. Its SmartBolus Calculator computes recommended bolus doses, while the app considers user-inputted carbohydrates and other sensor data. The recalled app is an Android-based software provided on either a locked-down controller or downloaded on a smartphone. Its uses include activating/deactivating pods, displaying alerts/alarms and sending insulin delivery commands.
Get the full story at our sister site, Drug Delivery Business News.