Home COVID Test Recall as FDA Recommends Throwing Kits Away

The U.S. Food and Drug Administration (FDA) has shared a recall for an at-home COVID-19 test after they were reportedly illegally imported into the country.

SD Biosensor Inc., a South Korean diagnostics company, recalled its "STANDARD Q COVID-19 Ag Home Test" due to "confirmed reports that the test kits were illegally imported into the United States," according to the recall notice posted on the FDA website.

The tests are not authorized, cleared or approved by the FDA for distribution or use in the U.S., according to the notice.

The notice says that although there is no known distribution of the tests directly to U.S. consumers, the manufacturer is issuing the recall "out of an abundance of caution."

"In the unlikely event that consumers in the United States encounter the 'STANDARD Q COVID-19 Ag Home Test,' they are encouraged to discard and avoid any use of the test, as it has not been authorized, cleared or approved by the FDA for use in COVID-19 testing and diagnosis in the United States," the notice says.

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

As well as the recall, SD Biosensor says it has launched an investigation to determine how the tests were illegally imported into the U.S.

The company is also "taking appropriate measures to prevent further attempts at illegal importation of unauthorized tests by strengthening contract terms and their enforcement with its distributors," the notice says.

"In addition, the company announced publicly that if such illegal importations are discovered in the future, the responsible individuals/distributors will face strict legal action and liabilities for damages."

SD Biosensor at home test kit
SD Biosensor recalled its "STANDARD Q COVID-19 Ag Home Test" due to "confirmed reports" that the test kits, which are not approved for use in the U.S., were illegally imported into the country. FDA

An FDA spokesperson referred Newsweek to the recall notice when contacted for further comment. SD Biosensor has been contacted for additional comment.

It comes after the Better Business Bureau (BBB) in January warned that scammers are using fake websites to steal information from Americans looking to order free at-home COVID-19 test kits from the government, as demand for testing spike following the spread of the highly contagious Omicron variant.

The Biden administration launched a website in January where people can order four free COVID-19 rapid test kits per households that will be delivered by the United States Postal Service.

The BBB warned people to be wary of "lookalike" websites where they may be asked to input personal information such as their Social Security, credit card or health insurance details. The federal website does not request any of this information.