SD Biosensor, a South Korean diagnostics company, recalled its Standard Q COVID-19 Ag Home Tests due to “confirmed reports that the test kits were illegally imported into the United States.”
The tests are not authorized, cleared or approved by the FDA for distribution or use in the U.S. The notice said although there is no known direct distribution of the tests to consumers, the manufacturer issued the recall “out of an abundance of caution.” The manufacturer will launch an investigation into how the tests were illegally imported into the country.
Consumers who used the tests are “strongly” encouraged to consider retesting with an FDA-authorized test.
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