Abbott has recently identified that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors provide incorrect low glucose readings. We learned about this through our ongoing product monitoring, where Libre 3 and Libre 3 Plus sensor users reported situations where they received incorrect low glucose readings. 

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

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. See how to locate the sensor serial number HERE.

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.

Abbott has identified and resolved the cause of the issue. The company continues to produce Libre 3 and Libre 3 Plus sensors to fulfill replacement and new orders and does not expect significant supply disruptions.

We have notified the regulatory authority in your country. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report online at www.fda.gov/medwatch.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

If you have additional questions or need to report any adverse reactions or quality problems experienced with the use of FreeStyle Libre 3 or FreeStyle Libre 3 Plus, please call Abbott Customer Service at 1-833-815-4273, available seven days a week from 8 a.m. to 8 p.m. Eastern Time. Agents are available 24/7 through live chat at https://www.freestyle.abbott/us-en/support/contact-us.html.