SD Biosensor Recalls Unauthorized COVID-19 Tests

Korea-based in-vitro diagnostics company SD Biosensor is recalling its Standard Q COVID-19 Ag home tests from the U.S. market.

The company acknowledged that the SARS-CoV-2 antigen test kits are not authorized, cleared or approved by the FDA and said it intended the products to be sold “in nonU.S. markets only.”

SD Biosensor does offer an FDA-authorized test, its COVID-19 At-Home Test, for sale in the U.S.