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FDA early alert for Abbott glucose monitor sensor issues
December 18, 2025

This article is for endocrinologists, PCPs, and durable medical equipment providers ordering and supplying glucose monitor sensors for our members

The U.S. Food and Drug Administration (FDA) has issued an early alert for Abbott Diabetes Care glucose monitor sensors.

  • Affected models include FreeStyle Libre 3 sensors (model numbers 72081-01; 72080-01) and FreeStyle Libre 3 Plus sensors (model numbers 78768-01; 78769-01).1
  • Abbott Diabetes Care will replace affected devices at no cost.

Why this is important: Incorrect low glucose readings can lead to wrong treatment decisions, posing serious health risks, including injury and death.

We cover continuous glucose monitoring devices, including the sensors, for our members using either their pharmacy benefits or medical benefits (via a durable medical equipment provider).

What to do

  • Inform your patients. Members should visit FreeStyleCheck.com to check if their sensor is affected and to request a replacement. Those receiving their devices via their pharmacy benefit are being notified by CVS Caremark.
  • Durable medical equipment providers should identify all recalled devices provided to members and immediately contact them to let them know about the recall. Please help members get their replacement device whenever possible. Share the link to FreeStyleCheck.com as needed.

Resources

Questions

Contact durable medical equipment network representative, Odette Palmer-Lee, at Odette.Palmer-Lee@bcbsma.com or call 1-617-246-5711. Thank you for helping to share this important information with our members.


  1. Abbot reports that the issue does not apply to the FreeStyle Libre 3 reader and app or any other Libre product.

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