FDAFDA · Food and drugs·Recall number Z-0478-2019
Insulia Diabetes Management Companion
Published November 28, 2018 · Recall initiated: October 8, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Voluntis
- Distributor
- 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).
- Lot
- Software version numbers 1.4.3 / 1.6.3 / 1.6.31 / 1.6.40
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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