What is the potential health risk to people with diabetes who are using an affected sensor?  

• If undetected, erroneously high glucose readings can pose a potential health risk for people living with diabetes.   
• Erroneously high glucose readings can lead to incorrect treatment decisions, such as taking insulin when not required.  

We have identified the root cause and were able to narrow the issue to a small subset of sensors.  

Yes. 

A small subset of sensors from 3 lots in the U.S. 

FreeStyle Libre 14 day, FreeStyle Libre 2, and FreeStyle Libre 2 Plus sensors are not affected. 

If you have a FreeStyle Libre 3 sensor from one of the affected lots, you can go to www.FreeStyleConfirm.com and enter your sensor serial number to determine if your sensor(s) are affected. 

If your sensor is still in its package, the serial number can be found on the bottom of the sensor carton packaging and on the sensor applicator label. For sensors in use or already used, the serial number can be found in the FreeStyle Libre 3 Reader or App.  

Reader: 

• From the Settings menu select System Status, then System Info. Multiple Sensor Serial Numbers may be listed. Number 1 is the one you are currently wearing or have most recently worn. 

App: 

• From the Main Menu select About. Multiple Sensor Serial Numbers may be listed. The one at the top of the list is the one you are currently wearing or have most recently worn.  

Please do not use the sensor if it has been confirmed to be affected. Immediately discontinue use and dispose of any affected sensors in your possession. Visit www.FreeStyleConfirm.com and we will send you a replacement sensor as soon as possible. We sincerely apologize for the inconvenience. 

Please immediately stop using the FreeStyle Libre 3 sensor and remove it from your arm. Visit www.FreeStyleConfirm.com and we will send you a replacement sensor as soon as possible. We sincerely apologize for the inconvenience. 

Please do not use the FreeStyle Libre 3 sensor if it has been confirmed to be affected. Visit www.FreeStyleConfirm.com and we will send you a replacement sensor as soon as possible. We sincerely apologize for the inconvenience. 

No other FreeStyle Libre family of products are affected. 

Please contact Customer Service at 1-833-815-4273. 

Please visit www.FreeStyleConfirm.com website to determine if your sensor is affected. If it is affected, please immediately discontinue use.  

Yes. You can request replacement product on www.FreeStyleConfirm.com. 

Yes. You can request replacement product on www.FreeStyleConfirm.com. 

No action is necessary, and you can continue to use your FreeStyle Libre family of products. 

We have communicated with the U.S. Food & Drug Administration. 

For each Sensor Kit that is impacted, please enter your Sensor Serial Number and provide your contact information for shipment of a replacement.  Please note, you can only enter one Sensor Serial Number at a time. Each time you enter a Sensor Serial Number, you will need to provide your contact information for shipment of a replacement. ​