FreeStyle Libre 3 Sensors Recalled for Incorrect Glucose Levels
This recall was posted 2 months ago. Check the FDA source for the latest status.
Class I Recall — Most Serious
This is a Class I recall — the most serious type. Products covered by this recall may cause serious health consequences or death.
Reported Health Impact
57
Illnesses
Abbott has announced a recall of certain FreeStyle Libre 3 and Libre 3 Plus glucose monitoring sensors in the United States due to potential incorrect low glucose readings. This issue could lead to incorrect treatment decisions for people with diabetes, posing serious health risks.
Affected Products:
- FreeStyle Libre 3 Sensors
- FreeStyle Libre 3 Plus Sensors
Reason for Recall:
Internal testing by Abbott revealed that some sensors may provide incorrect low glucose readings. This issue is linked to one production line, and Abbott has since resolved the manufacturing problem.
Consumer Guidance:
Consumers should visit www.FreeStyleCheck.com to check if their sensors are affected. Abbott will replace any impacted sensors at no charge. If a sensor is confirmed to be affected, users should stop using it immediately and dispose of it. Consumers should use a blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader for treatment decisions if sensor readings are inconsistent with symptoms.
Health Risks:
Incorrect glucose readings may lead to excessive carbohydrate intake or improper insulin dosing, which can result in serious health complications. Globally, there have been reports of 736 severe adverse events and seven deaths related to this issue, although no deaths have been reported in the U.S.
For more information or assistance, consumers can contact Abbott’s customer service at 1-833-815-4273 or visit www.FreeStyleCheck.com.
Where Products Were Sold
This recall affects products distributed nationwide across the United States.