FDA Issues Warning for Cue Health’s COVID-19 Tests (SNF/AL)

On October 16, the Food and Drug Administration (FDA) issued a warning regarding Cue Health’s two COVID-19 test kits, the Cue COVID-19 Test and the Cue COVID-19 Test for Home and Over the Counter Use. Due to reduced reliability of test results, the FDA recommends caregivers and home test users stop using Cue Health COVID-19 tests and dispose of the entire test cartridge in general waste. Providers should consider using a different FDA authorized COVID-19 test to retest individuals who tested negative on a Cue Health test but still have symptoms. Please report any problems you experienced using a Cue Health COVID-19 test to the FDA using the MedWatch FDA Safety Information and Adverse Reporting Program.