Frequently Asked Questions

What kind of field action is this? 

We’ve initiated a voluntary recall for customers in UK to let people know that certain sensors from a specific lot may provide incorrectly high sensor glucose readings.

Which products are involved?

Certain sensors from one lot of FreeStyle Libre 2 sensors shipped to the UK.

What is the problem?

Internal testing determined that certain sensors may provide incorrectly high glucose readings, which if undetected can pose a potential health risk for people living with diabetes.

Has a root cause been identified for this issue? 

We were able to narrow the issue to certain sensors. We’re currently investigating the root cause of this issue and will provide an update once available.

How did we find out about this issue?

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

Why do you have confidence that you can continue to ship FreeStyle Libre and FreeStyle Libre 2 sensors from other lots?

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

Where can I find the Sensor Kit Serial Number (S/N)?

If you are looking to check on a Sensor that is currently in use or has already been used, you can look up the Serial Number through the Reader or the FreeStyle LibreLink app.

If your Sensor is still in the original packaging the Serial Number can be found on the Sensor Applicator Label, Sensor Container Label and on the bottom of the Sensor Kit Carton. Click here for additional information.

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

Please immediately stop using the sensor. 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 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. 

What if I have a Sensor Kit in the original packaging that is affected?

Please do not use the 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.​

We will send you a mailing kit to return any affected sensor(s) to us.

Are other products affected besides the FreeStyle Libre and FreeStyle Libre 2 Sensor serial numbers indicated in the notification?

No. The situation only impacts certain sensors within a specific lot FreeStyle Libre 2 sensor kits. No other Abbott diabetes products are affected.

Will Abbott replace affected product?

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

ADC-69805 v2.0

Loading...