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Voluntis Recall: Insulia Diabetes Management Companion

Voluntis Recall: Insulia Diabetes Management Companion is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Voluntis; Product: Insulia Diabetes Management Companion; Reason for recall: The firm identified an issue with the basal calculator identified on the Android version of the Insulia ap

Recalling firmVoluntis
ProductInsulia Diabetes Management Companion
Reason for recallThe 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionDistributed 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).
Recall initiated20181008
Recall numberZ-0478-2019
Categorydevice
StateN/A
CountryFrance

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