FDA recall Z-0478-2019

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 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.

Distribution

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).

Key facts

Status

Terminated

Initiation date

2018-10-08

Report date

2018-11-28

Termination date

2019-03-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Suresnes, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0478-2019