URGENT FIELD SAFETY NOTICE
FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors
URGENT FIELD SAFETY NOTICE
FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors
Abbott has recently identified FreeStyle Libre 3 and 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 or FreeStyle Libre 2 Plus sensor.
This issue affects a subset of FreeStyle Libre 3 and 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 and FreeStyle Libre 3 Plus sensors, please call Abbott Customer Service at 0800 170 11 77, Mon - Fri (8.00 - 20.00) Sat, Sun & Bank Holidays (9.00 - 17.00)
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