Z-0478-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2018
- Initiation Date
- October 8, 2018
- Termination Date
- March 12, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14
Product Description
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 Pattern
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).
Code Information
Software version numbers 1.4.3 / 1.6.3 / 1.6.31 / 1.6.40