Earlier this year, the FDA said an inspection found 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 said these changes reduced the reliability of the tests to detect SARS-CoV-2, the virus causing COVID-19.
Because this led to the risk of false results, the FDA issued a warning for Cue’s COVID-19 tests in May. That included its home and over-the-counter (OTC) use as well as a test intended for patient care settings. Not long after the warning, the company laid off all remaining U.S. employees (around 230). By the end of May, Cue Health filed for Chapter 7 bankruptcy.
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 FDA now considers the Cue Health recall Class II, issued when the use of a product may cause a temporary or medically reversible adverse health consequence, or where the probability of serious adverse health consequences is remote. According to the agency, on Oct. 9, it revoked the EUAs for both of Cue Health’s test kits.