Frequently Asked Questions

What kind of field action is this? 

We’ve initiated a voluntary medical device correction to let people know that a small subset of FreeStyle Libre 3 sensors may provide incorrect high sensor glucose readings.

Which products are involved?

Certain sensors from three (3) lots of FreeStyle Libre 3 sensors, listed below, that were distributed in the U.S. 

T60001948 

T60001966 

T60001969 

What is the problem?

Internal testing determined that certain sensors from three (3) lots may provide incorrect high glucose readings, which if undetected may pose a potential health risk for people living with diabetes. 
 

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.  

Has a root cause been identified for this issue?

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

How did we find out about this issue?

Abbott became aware of this issue through our internal testing and investigation processes.

Are you still shipping FreeStyle Libre 3 sensors?

Yes. 

Why do you have confidence that you can continue to ship FreeStyle Libre 3 sensors from other lots?

Abbott has a comprehensive quality testing system. We were able to narrow the issue to a small subset of sensors. 

How many sensors were affected?

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

Are FreeStyle Libre 14 day, or FreeStyle Libre 2 or FreeStyle Libre 2 Plus sensors affected?

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

Where can I find the sensor serial number?

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. 

sensor serial number

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.  

Can I still use my unused FreeStyle Libre 3 sensor if it is affected by this issue?

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. 

What if I am currently wearing a FreeStyle Libre 3 sensor that is affected?

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. 

I recently wore a sensor that was affected. What do I need to do?

Please go to www.FreeStyleConfirm.com and we will send you a replacement sensor as soon as possible. We sincerely apologize for the inconvenience.

What if I have a sensor kit in the original packaging that is affected?

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. 

Are other products affected besides the FreeStyle Libre 3 Sensor serial numbers indicated in the notification?

No other FreeStyle Libre family of products are affected. 

What should I do if I’m experiencing high glucose readings, yet my serial number is not on the affected list? 

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

Is it safe to use sensors from the affected lots? 

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

Will Abbott replace affected product? 

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

Is replacement product available? 

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

What if my product was not included in the voluntary recall? 

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

Have any regulatory authorities been contacted? 

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

What if I have more than one Sensor Kit that is impacted? ​ 

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. ​

ADC-96094 V1.0

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