medical Class I Updated 2022-03-23

SD Biosensor, Inc. recalls STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag H

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: REF No. Q-NCOV-03G Catalog No.: 09COV130 Lot Number: 59628J1T1 (Potentially 59628J1T1/2)
View official government recall

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