This warning extends to COVID-19 tests for home and over-the-counter (OTC) use as well as a test intended for patient care settings. According to the FDA, it issued the warning as a result of an increased risk of false results.

In an FDA notice, the agency said it issued a warning letter to Cue Health on May 10, 2024. An inspection revealed that the company made changes to tests that previously garnered emergency use authorization (EUA) in 2020 and 2021. Cue Health also won FDA de novo clearance for its at-home and point-of-care molecular COVID-19 test last year. The FDA says these changes reduced the reliability of the tests to detect SARS-CoV-2, the virus causing COVID-19.