Illegally imported COVID-19 tests are being voluntarily recalled, FDA encourages ‘discard, avoid any use’

The Food and Drug Administration has shared a voluntary recall of the Standard Q COVID-19 AG Home Test after reports have confirmed the tests were illegally imported into the US.

The STANDARD Q COVID-19 Ag Home Test is not authorized, cleared or approved by the U.S. FDA for distribution or use in the United States,” according to FDA. “While there is no known distribution of these tests directly to consumers, SD Biosensor, Inc. is issuing this voluntary recall out of an abundance of caution.”

As the tests have not been authorized to be used in the U.S., the FDA is encouraging those with the Standard Q COVID-19 Ag Home Tests to “discard and avoid any use.”

“Consumers that have used the test are strongly encouraged to consider retesting with an FDA authorized or cleared test.”