FDA confirms recalls for Abbott CGM sensors—new lawsuit alleges company concealed information
The U.S. Food and Drug Administration (FDA) has finalized four new recalls for certain lots of Abbott’s FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors due to ongoing safety concerns. These are Class I recalls, which means the FDA believes using these devices may be associated with a risk of serious injury or death.
In November, Abbott warned the public that some of its continuous glucose monitoring (CGM) sensors were providing incorrect low glucose warnings. Internal testing identified the issue—carbon building up in the sensors during the manufacturing process—and determined that approximately 3 million CGM sensors were affected. The sensors were distributed in the United States, Canada and several European countries.
“If undetected, incorrect low glucose readings over an extended period may lead to incorrect treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses,” Abbott said at the time. “These decisions may pose serious health risks, including potential injury or death, or other less serious complications.”
As of Nov. 14, this sensor issue had been linked to 736 serious injuries and seven patient deaths around the world. Fifty-seven of those severe adverse events occurred in the United States, but there were no deaths.
When Abbott shared that announcement, the FDA was still reviewing the situation. No recalls had yet been finalized. Now, however, the agency has announced four new Class I recalls.
Consumers are asked to visit www.FreeStyleCheck.com to confirm whether or not their sensor is potentially impacted by this issue. Abbott has said it replace sensors as necessary at no charge. Anyone currently wearing a sensor that is part of this correction should stop using it immediately.
No other Abbott CGM sensors, readers or apps are impacted by this issue, the company emphasized in its statement.
Patient files lawsuit over sensor risks
At least one patient has filed a lawsuit against Abbott over this issue. The plaintiff, a Florida resident who uses Abbott’s Freestyle Libre 3 and Freestyle Libre 3 Plus sensors to help manage his diabetes, said he “experienced dangerously inaccurate glucose readings when compared to actual fingerstick measurements.”
According to the class action complaint against Abbott Diabetes Care and Abbott Laboratories—filed in the U.S. District Court of the Northern District of California and first shared online by AboutLawsuits—the plaintiff alleges that Abbott knew about this defect but concealed it from the public at first. He is seeking “all monetary and nonmonetary relief allowed by law” and demanding a jury trial.
Abbott comments on class action complaint
An Abbott spokesperson shared a statement with Cardiovascular Business about this lawsuit:
"We’re committed to ensuring the safety and quality of our products. Our quality system monitors how products perform when customers use them to ensure they’re working as intended. If we see any indication of a potential issue, we review and resolve it. FreeStyle Libre systems are used by millions of people with diabetes worldwide, and we stand by this revolutionary technology. This lawsuit is without merit."
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.