Insulia Diabetes Management Companion
FDA Recall Z-0478-2019 · Posted None
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Recalling FirmVoluntis
Recall StatusTerminated
Product CodeNDC
Date Initiated2018-10-08
Date Terminated2019-03-12
Product Quantity14
Reason for Recall
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.
Firm 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 assistance or if you have any questions, please contact the Insulia support hotline.
Root Cause
Software in the Use Environment
Distribution Pattern
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).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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