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Some FreeStyle Libre 3 plus glucose monitor sensors may provide incorrect low glucose readings, Health Canada said in an alert.
Abbott Diabetes Care recalled certain types of its FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensor kits that it says were linked to seven deaths and more than 700 injuries.
“If undetected, incorrect low glucose readings over an extended period may lead to incorrect treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses,” Health Canada said in an alert posted Wednesday.
Serious health risks, including potential injury or death, or other less serious complications, can result from those decisions, the Canadian regulator said.
Health Canada said users should locate their sensor serial number and visit www.freestylecheck.com to determine if they have potentially impacted product .
“If confirmed immediately discontinue use, dispose of the affected sensor and request a replacement.”
The U.S. Food and Drug Administration also warned people to stop using the recalled glucose monitor sensors.
The sensors are devices that measure glucose levels in fluid just beneath the skin to provide real-time measurements of glucose, or sugar, in the blood. Information from the sensor is sent wirelessly to a device or phone.
3 million sensors affected in U.S.
The warning affects about three million sensors in the U.S. from a single production line, Abbott officials said in a statement.
About half those devices have expired or been used, the company added. As of Nov. 14, the company reported seven deaths worldwide and 736 serious adverse events. No deaths occurred in the U.S., where 57 injuries were reported.
Abbott says it has notified all customers of the problem. The company said it has identified and resolved the issue in the affected production lot.
The FDA said people should stop using affected sensors and discard them.
The problem involved FreeStyle Libre 3 sensors with model numbers 72080-01 with unique device identifiers 00357599818005 and 00357599819002.
It also involved FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01 and unique device identifiers 00357599844011 and 00357599843014.
People can visit www.FreeStyleCheck.com to check if their sensors are potentially affected and request a replacement, the company said. No other FreeStyle Libre products are affected.
