SD Biosensor, Inc. recalls STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qual

Recalled March 23, 2022 · FDA recall Z-0719-2022 · SD Biosensor

Hazard

Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S. · FDA Class I

Units

~400,000 kits

Sold at

U.S. Nationwide Distribution

Description

Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.

Product

STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.

Manufacturer(s)

SD Biosensor, Inc.

Made in

Korea (the Republic of)

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →