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FDA recalls illegally imported COVID-19 Ag Home Test kits

On February 4, 2022, The U.S. Food and Drug Administration (FDA) has posted a recall for a COVID-19 Ag Home Test because there are reports of the test kits illegally imported into the country.

The FDA says the tests, which are the Standard Q COVID-19 Ag Home Test kit, come from SD Biosensor, Inc. These tests were distributed into the U.S., but were not cleared, authorized, or approved by the FDA. Below is a picture of the test kit that was illegally brought into the country.

Besides a voluntary recall, SD Biosenesor, Inc. is also conducting an investigation to determine how the tests were illegally imported. The company says it is taking measures to prevent further illegal importation. If there are future importations discovered, the individuals or distributors will face legal action and liabilities for damages, according to the company.

The FDA recommends any consumer with the Standard Q COVID-19 Ag Home Test is asked to throw it away and avoid any use of the test. Those who have used this test are asked to rest with an FDA authorized or cleared test.



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