FDA警告不要进行COVID-19检测，提示健康状况下滑

Cue Health (NASDAQ:HLTH) shares extended a multi-day decline in the premarket Tuesday after the U.S. Food and Drug Administration (FDA) warned against using the company’s COVID-19 tests due to the increased risk of false results.

The agency noted that an inspection has revealed that Cue Health (HLTH) has made unauthorized changes to the product, impacting its reliability in detecting the COVID-19 virus.

The San Diego, California-based HealthTech markets COVID-19 tests for point-of-care settings, at-home, and over-the-counter use in line with the emergency use authorizations it received in 2020 and 2021.

“The FDA is warning home test users, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests due to this increased risk of false results,” the agency warned.

The FDA posted its warning in a safety communication on Monday after issuing a warning letter to the company last week. 

In a press release late Monday, Cue Health (HLTH) said it received the FDA’s warning letter and noted that its management is evaluating the response. “The company is currently evaluating the letter and determining its response, with more information to follow in the next few days,” HLTH said.