Medical device giant Abbott announced on Sunday that it is recalling approximately 3 million glucose monitoring sensors after discovering they could give dangerously inaccurate low blood sugar readings.
The company said the faulty FreeStyle Libre 3 and Libre 3 Plus sensors have been linked to 736 severe adverse events worldwide, including 57 in the United States, and seven deaths outside the United States.
The recall highlights ongoing safety concerns with continuous glucose monitors, which millions of people with diabetes rely on for real-time blood sugar data.
False low readings could prompt users to consume unnecessary carbohydrates or skip insulin doses, potentially causing serious health complications.
Abbott traced the problem to a single production line among several that manufacture the sensors. The company said it has fixed the issue and expects no major supply disruptions.
About half of the affected sensors have likely expired or been used already. Consumers can check whether their sensors are impacted at www.FreeStyleCheck.com and request free replacements.
“If consumers are currently wearing or have a sensor that has been confirmed as potentially impacted on www.FreeStyleCheck.com or by a customer service representative, they should immediately discontinue use and dispose of it,” Abbott stated in a news release.
The company urged users to verify glucose readings with traditional finger-stick meters when sensor results don’t match their symptoms. Customer service representatives are available at 1-833-815-4273 seven days a week.
Other FreeStyle Libre products, including the 14-day, Libre 2, and Libre Pro sensors, remain unaffected. The recall extends to other countries where Abbott distributes the Libre 3 and Libre 3 Plus sensors.
Abbott, which employs 114,000 people globally, develops healthcare technologies spanning diagnostics, medical devices, and pharmaceuticals. The Illinois-based company serves customers in more than 160 countries.
