NYSDA Publications

FDA Issues Safety Alert on Counterfeit COVID-19 Tests

The United States Food and Drug Administration (FDA) has issued a safety alert about counterfeit at-home over-the-counter (OTC) novel coronavirus (COVID-19) diagnostic tests being distributed or used in the United States.  FDA notes that counterfeit COVID-19 tests are tests that are not authorized, cleared, or approved by the FDA for distribution or use in the United States, but are made to look like authorized tests so the users will think they are the real, FDA-authorized test.  FDA further notes that the performance of these counterfeit COVID-19 tests has not been adequately established and the FDA is concerned about the risk of false results when people use these unauthorized tests.  To read the FDA safety alert on counterfeit COVID-19 tests, use the link below.