The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The SD Biosensor STANDARD Q COVID-19 Ag Home Test uses a nasal swab sample to detect proteins, called antigens, from SARS-CoV-2, the virus that causes COVID-19. This test is not authorized, cleared, or approved by the FDA for marketing or distribution in the United States.