Reported Nov 28, 2018 · Terminated
Insulia Diabetes Management Companion
Voluntis
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Voluntis · 22 Quai Gallieni · Suresnes, N/A · N/A
Is this the product you have?
- Insulia Diabetes Management Companion
- Lot codes and dates
- Software version numbers 1.4.3 / 1.6.3 / 1.6.31 / 1.6.40
- Amount recalled
- 14
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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