FDA recalls illegally imported at-home COVID-19 test kits

Recalls and Consumer Alerts

(Photo courtesy: FDA)

(WFXR) — The U.S. Food and Drug Administration (FDA) has posted a recall for an at-home COVID-19 test because they have reportedly been 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.

(Photo courtesy: FDA)

In addition to a voluntary recall, SD Biosensor, Inc. is 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 throw it away and avoid using it. Those who have used this test are asked to retest with an FDA-authorized or -cleared test.

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