URGENT MEDICAL DEVICE RECALL  

FreeStyle Libre 3 Plus Sensors

Abbott has recently identified FreeStyle Libre 3 Plus sensors that may provide incorrect low glucose readings, which if undetected may pose a potential health risk for people living with diabetes.   

This issue does not apply to the FreeStyle Libre 3 reader and app or any other Libre product (FreeStyle Libre 2).  

 

This issue affects a subset of FreeStyle Libre 3 Plus sensors. To determine if your current sensor or any unused sensor(s) are potentially affected, go to  CONFIRM SENSOR SERIAL NUMBER.

Verify your sensor's expiration date and discard any that have expired

 

Potential Harms

If undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions may pose serious health risks, including potential injury or death, or other less serious complications.

Use a blood glucose meter or the built-in meter in your FreeStyle Libre 3 Reader to make treatment decisions when your sensor readings don’t match your symptoms or expectations.

We have notified the regulatory authority in your country.

If you have additional questions or need to report any adverse reactions or quality problems experienced with the use of FreeStyle Libre 3 Plus sensors, please call Abbott Customer Service at 1-855-421-6177, available Monday to Friday 8am to 9pm and Saturday and Sunday 9am to 5pm, excluding holidays.

ADC-123464 v1.0

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