Health Canada has issued a warning regarding the FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose monitor sensors, citing potential inaccuracies in low glucose readings. Abbott Diabetes Care has initiated a recall of specific sensor kits, linked to seven fatalities and over 700 injuries. The incorrect low glucose readings could lead to improper treatment decisions for individuals with diabetes, posing severe health risks such as excessive carbohydrate consumption or insulin dosage errors.
Users are advised by Health Canada to check their sensor serial numbers on www.freestylecheck.com to verify if they are using the impacted products. If confirmed, users should discontinue use immediately, dispose of the affected sensors, and request replacements. The U.S. Food and Drug Administration has also cautioned against using the recalled sensors.
The sensors, designed to measure glucose levels beneath the skin and provide real-time blood glucose measurements, have affected approximately three million units in the U.S. from a specific production line. Abbott officials disclosed that around half of these devices have either expired or been used. As of the latest update, there have been seven global fatalities and 736 serious adverse incidents, with no reported deaths in the U.S., but 57 injuries documented.
Abbott has informed all customers of the issue and stated that they have rectified the problem in the relevant production batch. Individuals are urged by the FDA to cease using the affected sensors and discard them. The problematic sensors bear model numbers 72080-01 and 78768-01, with unique device identifiers 00357599818005, 00357599819002, 00357599844011, and 00357599843014 for FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors.
To determine if their sensors are potentially impacted, individuals can visit www.FreeStyleCheck.com to request replacements. Abbott has assured that no other FreeStyle Libre products are affected by this recall.
