Health product recall

FreeStyle Libre® 3 Plus Sensor Kit

Last updated

Summary

Product
FreeStyle Libre® 3 Plus Sensor Kit
Issue
Medical devices - Performance
What to do

FreeStyle Libre® 3 Plus Sensor users should locate their sensor serial number and visit www.freestylecheck.com to determine if they have potentially impacted product. If confirmed immediately discontinue use, dispose of the affected sensor and request a replacement. 

Affected products

Affected products Lot or serial number Model or catalogue number
FreeStyle Libre® 3 Plus Sensor Kit T60003532 78791-01
FreeStyle Libre® 3 Plus Sensor Kit T60003598 78791-01
FreeStyle Libre® 3 Plus Sensor Kit T60003627 78791-01
FreeStyle Libre® 3 Plus Sensor Kit T60003522 78791-01
FreeStyle Libre® 3 Plus Sensor Kit T60003509 78791-01
FreeStyle Libre® 3 Plus Sensor Kit T60003554 78791-01
FreeStyle Libre® 3 Plus Sensor Kit T60003503 78791-01
FreeStyle Libre® 3 Plus Sensor Kit T60003216 78791-01

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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies

Abbott Diabetes Care Ltd.

Range Road, Witney, Oxfordshire, United Kingdom, OX290YL

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Recall date
Identification number
RA-81314

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