(ABC4) – As COVID-19 at-home testing kits become accessible, a certain testing kit is being recalled due to reports of illegally imported tests into the U.S.
The Food and Drug Administration (FDA) says the company, SD Biosensor, Inc., has voluntarily recalled their STANDARD Q COVID-19 Ag Home Test.
The home test is a “rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.”
Officials say the test has not been authorized for sale or distribution in the U.S. Officials say there is no known direct-to-customer distribution of these tests so far, but the recall will be issued out of caution.
Authorities are investigating how the tests were illegally imported into the country.
“SD Biosensor, Inc. is taking appropriate measures to prevent further attempts at illegal importation of unauthorized tests by strengthening contract terms and their enforcement with its distributors,” officials say. “In addition, the company announced publicly that if such illegal importations are discovered in the future, the responsible individuals/distributors will face strict legal action and liabilities for damages.”
Anyone who may own this specific testing kit is advised to discard it immediately. To view the full FDA recall announcement, click here.