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
RecallTracker