Recall Z-0478-2019 ยท NDC Calculator, Drug Dose
Voluntis
Insulia Diabetes Management Companion
| Date | Oct 8, 2018 |
| Status | Terminated |
| Reason | The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending on the circumstances. A new update of Insulia is now available (version 1.6.42), which resolves this issue. |
| Root cause | Software in the Use Environment |
| Action | On October 15, 2018, patients were notified that they could download the new version of the application from the Google Play Store. The notification was made through an automated message displayed on the application screen of all impacted patients requesting them to update their Insulia application. Patients were informed that the new version of the app resolved a an issue with the basal calculator identified on the Android version of the application. Patients who do not upgrade to the new version by November 9, 2018 will be blocked from using the app until they upgrade. For technical assista |
| Quantity | 14 |
| Distribution | Distributed to accounts in Arizona, Masachusetts, Michigan, Ohio, Tennessee, and Vermont. International distribution to Canada and France (however, French customers are not affected by this recall). |
| FDA record | Open on fda.gov |