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Freestyle libre sensor kits
Official notice
16 Feb 2023
Last checked
16 Feb 2023
An official Health Canada notice concerns Freestyle libre sensor kits. 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 Published 2023-02-16.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72684
Official notice
2023-02-16
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
Lots
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Affected products
Product 1
Product 2
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Abbott Diabetes Care, Freestyle Libre Sensor Kits.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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