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Health Canada Medical devices

FreeStyle Libre® 3 Plus Sensor Kit

Issued December 3, 2025
Issue
A subset of FreeStyle Libre® 3 plus sensors may provide incorrect low glucose readings. If undetected, incorrect low glucose readings over an extended period may lead to incorrect treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions may pose serious health risks, including potential injury or death, or other less serious complications.
Hazard description
Performance
Product
Product name
FreeStyle Libre® 3 Plus Sensor Kit
Reference
ID
RA-81314