FDAJanuary 31, 2022device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
sd biosensor
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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