Freestyle Libre Sensor Kits
Brand(s)
Summary
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
Abbott Diabetes Care Ltd.
Range Road, Witney, Oxfordshire, Great Britain, OX290YL