Public recall detail

FreeStyle Libre® 3 Plus Sensor Kit

2025-12-03

medium
Recall Safety notice
Quick summary

Quick summary: FreeStyle Libre® 3 Plus Sensor Kit. Date: 2025-12-03.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: FreeStyle Libre® 3 Plus Sensor Kit. Date: 2025-12-03.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAbbott Diabetes Care Ltd.
ProductFreeStyle Libre® 3 Plus Sensor Kit
IssueMedical devices - Performance
Recall classType II
IdentificationRA-81314

Affected products

ProductFreeStyle Libre® 3 Plus Sensor Kit
LotT60003522
Model78791-01
Serial numberT60003522
DescriptionFreeStyle Libre® 3 Plus Sensor Kit
ProductFreeStyle Libre® 3 Plus Sensor Kit
LotT60003216
Model78791-01
Serial numberT60003216
DescriptionFreeStyle Libre® 3 Plus Sensor Kit

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.

What you should 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.
Additional official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Medical devices - Gastroenterology and urology
CompaniesAbbott Diabetes Care Ltd. Range Road, Witney, Oxfordshire, United Kingdom, OX290YL
Recall date2025-11-24
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81314
Background{}
CompaniesAbbott Diabetes Care Ltd. Range Road, Witney, Oxfordshire, United Kingdom, OX290YL
AudiencesGeneral public Healthcare Industry
Source updated2025-12-03

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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