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.
Users should cease use of any Cue Health COVID-19 tests still in their possession, the agency said. The FDA instructed users to dispose of the entire test cartridge in the trash.
Cue Health’s test kit runs on the Cue Reader and includes a single-use COVID-19 cartridge and Cue Wand. The test requires no mixing of fluids or complex testing and was designed to eliminate the need to send samples to a lab, hire healthcare professionals, or perform additional confirmatory tests.
The company issued a brief statement following its receipt of the warning letter from the FDA:
Cue Health Inc., a healthcare technology company, has received a warning letter from the FDA about its Emergency Use Authorized (EUA) COVID-19 test. The company is currently evaluating the letter and determining its response, with more information to follow in the next few days.
