SD Biosensor, Inc., an in-vitro diagnostics company, is recalling its STANDARD Q COVID-19 Ag Home Test in the United States, the U.S. Food and Drug Administration announced. The action is due to confirmed reports that the test kits were illegally imported into the country.
The STANDARD Q COVID-19 Ag Home Test is not authorized, cleared or approved by the FDA for distribution or use in the U.S. The agency noted that there is no known distribution of these tests directly to consumers, but they are being recalled out of an abundance of caution.
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. It provides only an initial screening test result. The FDA said the result of this test should not be the sole basis for the diagnosis, and that con?rmatory testing is required.
If consumers encounter the home test, they are asked to discard and avoid any use of the test. Consumers who have used the test are strongly encouraged to consider retesting with an FDA authorized or cleared test.
Along with the recall, SD Biosensor has initiated an investigation to determine how the product was illegally imported into the U.S. Distributors or individuals who illegally imported the products initially sold outside the U.S. will be ordered to stop the illegal activity and initiate an immediate product recall.
Responsible individuals/distributors for the illegal importation will face strict legal action and liabilities for damages.
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