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FDA Issues Alert on FreeStyle Libre 3 Sensor Recall

- by Maryann Pugh
FreeStyle Libre 3 sensorsSubmitted Image

WASHINGTON, D.C. — The Food and Drug Administration (FDA) announced that Abbott has initiated a voluntary recall for a specific batch of FreeStyle Libre® 3 sensors distributed in the U.S. during early May 2024. The recall only affects the sensor component of the FreeStyle Libre 3 system, which also includes a reader and an app.

Internal tests revealed that some sensors from three specific lots might provide inaccurate high glucose readings. This could pose a health risk for people with diabetes by potentially leading to incorrect insulin dosing.

Affected Lots

The recall concerns a small number of sensors from the following lot numbers:

  • T60001948
  • T60001966
  • T60001969
Identifying Affected Sensors

To check if a sensor is from an affected lot, consumers can find the lot and serial numbers on the packaging or, if the sensor is already in use, within the FreeStyle Libre 3 app or reader. Detailed instructions are available at www.FreeStyleConfirm.com.

Steps for Consumers

If consumers find their sensor is from one of the affected lots, they should:

  1. Visit www.FreeStyleConfirm.com and select “Confirm Sensor Serial Number.”
  2. Enter the sensor’s serial number to verify if it is part of the recall.
  3. If confirmed, discontinue use immediately and dispose of the sensor.
  4. Enter contact information on the website to receive a free replacement sensor from Abbott.
Official Statement

“We sincerely regret the disruption this may have on our customers,” said Jared Watkin, executive vice president of Abbott’s diabetes care business. “We’re actively working with the U.S. Food and Drug Administration and distributors, as well as providing information to affected customers, who will receive replacements at no charge as quickly as possible.”

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Additional Guidance

Consumers should perform a fingerstick test using any blood glucose meter if they experience symptoms inconsistent with their sensor readings or suspect inaccuracies. The built-in blood glucose meter in the FreeStyle Libre 3 reader can be used for this purpose.

For more information or assistance, consumers can call customer service at 1-833-815-4273, available from 8 a.m. to 8 p.m. Eastern Time, excluding holidays.

The recall does not affect users outside the U.S. or those using other FreeStyle Libre products such as the FreeStyle Libre 14 day, FreeStyle Libre 2, or FreeStyle Libre 2 Plus systems.

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