Health product recall

Freestyle Libre Sensor Kits

Last updated

Summary

Product
Freestyle Libre Sensor Kits
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Affected products

Affected products Lot or serial number Model or catalogue number
Freestyle Libre Flash Glucose Monitoring System - Sensor Kit KTP005058 71534-01
Freestyle Libre 2 Sensor Kit KTP005080 71993-01

Issue

It was identified that two (2) Freestyle Libre sensor reel lots manufactured by Abbott Diabetes Care (ADC) failed retain testing. As a result of the investigation and testing of retains, the sensors were found to give clinically significant readings results; sensors may provide erroneous high sensor glucose results. These sensor reel lots were manufactured into six (6) finished goods lots (Freestyle Libre and Freestyle Libre 2
sensors) and distributed to the field. The lots have been distributed to Japan, Canada, Saudi Arabia, and United Kingdom. In Canada, this issue affects a subset of Freestyle Libre® 2 sensors with the lot number KTP005080 and Freestyle Libre® sensors with the lot number KTP005058.  If you have these lot numbers, please visit  www.freestyleconfirm.com to see if your sensor is impacted.

Recall start date: February 3, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Health products - Medical devices - Gastroenterology & Urology
Companies

Abbott Diabetes Care Ltd.

Range Road, Witney, Oxfordshire, Great Britain, OX290YL

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-72684

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