FDA: Class I recall of SD Biosensor Standard Q COVID-19 Ag Home Test

Editor's Note

The Food and Drug Administration (FDA) on March 16, designated the recall of SD Biosensor’s Standard Q COVID-19 Ag Home Test as Class I, the most serious.

The recall was initiated because the test, which uses a nasal swab sample to detect COVID-19 antigens, is not authorized, cleared, or approved by the FDA for marketing or distribution in the US.

This recall does not apply to the SD Biosensor COVID-19 At-Home Test, which was authorized by the FDA on December 24, 2021, and is distributed by Roche Diagnostics.

There have been no reports of injuries, adverse health consequences, or deaths associated with the SD Biosensor Standard Q COVID-19 Ag Home Test.

Distribution dates were August 26, 2021 to January 30, 2022.