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SD Biosensor Issues Voluntary US Recall of Unauthorized COVID-19 Antigen Test

NEW YORK ─ SD Biosensor on Tuesday announced a voluntary US recall of its Standard Q COVID-19 Ag Home Test because of confirmed reports that the test kits have been illegally imported.

The South Korea-based developer said its test — a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in a nasal sample — is neither authorized, cleared, nor approved for distribution or use in the US by the US Food and Drug Administration.

Outside the US, the antigen test provides an initial result for screening purposes but its results should not be the sole basis for a diagnosis, the firm said.

"In the unlikely event that consumers in the United States encounter the Standard Q COVID-19 Ag Home Test, they are encouraged to discard and avoid any use of the test," SD Biosensor said in a statement.

Though there has been no confirmation that the tests have been distributed to consumers, SD Biosensor is issuing the recall out of an abundance of caution, it said. The company added that the recall does not impact the distribution and use of the COVID-19 At-Home Test for which SD Biosensor recently received FDA Emergency Use Authorization. Roche Diagnostics is an authorized distributor of that test.

The recall is the second in the last week of COVID-19 tests. On Friday, the FDA issued a warning telling people to stop using two tests produced by Empowered Diagnostics — its CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.