FDAOctober 8, 2018device

Insulia Diabetes Management Companion

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Terminated

Brands named

voluntis

Recall history

No related federal recalls on record for this brand yet.

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