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Voluntis recalls Insulia Diabetes Management Companion
Recalled November 28, 2018 · FDA recall Z-0478-2019 · Voluntis
Hazard
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. · FDA Class II
Units
14
Sold at
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).
Description
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.
Product
Insulia Diabetes Management Companion
Manufacturer(s)
Voluntis
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →