On October 16, 2024, the Food and Drug Administration (FDA) issued an updated warning regarding Cue Health’s COVID-19 tests due to the risk of false results.
If you have Cue Health COVID-19 tests, the FDA recommends that you stop using them immediately and dispose of the entire test cartridge in your general waste. Providers should retest patients using a different FDA-authorized test if an inaccurate result is suspected from a Cue COVID-19 test. However, if testing occurred more than two weeks ago and there are no current symptoms or reasons to suspect a SARS-CoV-2 infection, retesting is not necessary.
Providers are encouraged to report any issues encountered with the Cue Health COVID-19 test, including suspected false results, to the FDA. For more information, see Reporting Problems with Your Test.