Recall MonitorHealth Products
FreeStyle Libre 3 App
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: FreeStyle Libre 3 App
Issue: Medical devices - Device compatibility, Medical devices - Performance
What to do: For further details on this recall, please refer to the manufacturer's website at: HTTPS://WWW.LIBRECHECK.COM/EN-CA/HOME.HTML
Audience: General public
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| FreeStyle Libre 3 App (Android) | version 3.6.4 | V3.4 |
| FreeStyle Libre 3 App (Android) | version 3.6.7 | V3.4 |
| FreeStyle Libre 3 App (Android) | version 3.6.8 | V3.4 |
| FreeStyle Libre 3 App (Android) | version 3.6.5 | V3.4 |
| FreeStyle Libre 3 App (Android) | version 3.6.6 | V3.4 |
| FreeStyle Libre 3 App (iOS) | version 3.6.4 | V3.4 |
| FreeStyle Libre 3 App (iOS) | version 3.6.7 | V3.4 |
| FreeStyle Libre 3 App (iOS) | version 3.6.8 | V3.4 |
| FreeStyle Libre 3 App (iOS) | version 3.6.5 | V3.4 |
| FreeStyle Libre 3 App (iOS) | version 3.6.6 | V3.4 |
Issue
Abbott has identified an important security update for the FreeStyle Libre 3 App. This software update is required to maintain security of the apps. Following the security update to the FreeStyle Libre 3 App (Android and iOS), the software update implemented to mitigate the sensor impersonation vulnerability introduced an unintended defect that, under certain conditions, can result in prolonged loss of communication between the mobile application and the sensor. Customers are advised to immediately update their app to the latest version 3.6.10 to rectify the issues.