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 qualit…

Recall date

January 31, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0719-2022

FDA classification

Class I

Brand / firm

SD Biosensor, Inc.

Sold / distributed

U.S. Nationwide Distribution

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.