Voluntis recalls Insulia Diabetes Management Companion

Recall date

October 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0478-2019

FDA classification

Class II

Brand / firm

Voluntis

Sold / distributed

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).

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Insulia Diabetes Management Companion