Abbott Recall Small Number of FreeStyle Libre 3 SensorsAbbott Recall Small Number of FreeStyle Libre 3 Sensors

Abbott Laboratories has initiated a voluntary recall of a small number of FreeStyle Libre 3 sensors within three lots distributed throughout the US. Designed to be what the company says is the world’s smallest sensor, the continuous glucose monitor (CGM) is considered one of the big players in the diabetes market, along with Dexcom’s G7.

The recall of FreeStyle Libre 3 only pertains to the sensor — one of the three parts of the system, including the sensor, reader, and app. Affecting sensors distributed during the first half of May 2024, Abbott wrote that internal testing unveiled that some sensors from lots T60001948, T60001966, and T60001969 may provide incorrect high glucose readings. If these incorrect readings were to go undetected, it may pose health risks for patients and could lead to taking too much insulin and other incorrect treatment decisions.

If experiencing symptoms that do not match the CGM reading or if it is suspected that the reading is inaccurate, Abbott recommends customers conduct a fingerstick test using any blood glucose meter.

For customers, Abbott said in the recall notice to check the lot or serial number to determine if a device in use is part what is being recalled. To do this, it is recommended to locate the product package and find the serial number (identified as SN) on the bottom of the packaging, and if packaging is unavailable, the SN is displayed within the FreeStyle Libre 3 app or reader.

If the sensor is found to be faulty, customers should immediately discontinue use and dispose of any recalled sensors. Abbott will replace affected sensors at no charge.

"We sincerely regret the disruption this may have on our customers," said Jared Watkin, executive vice president of Abbott’s diabetes care business, in the company press release. "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."

The company reiterated that the only item being recalled is the sensor of the FreeStyle Libre 3, meaning that the reader and app are not impacted. Additionally, sensors from lots outside of the three noted can continue to be used and there is no impact to users outside of the US.