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Voluntary recall issued for at-home COVID-19 test illegally imported into the United States

According to the FDA, these tests are not authorized, cleared or approved for distribution or...
According to the FDA, these tests are not authorized, cleared or approved for distribution or use in the United States.(FDA)
Published: Feb. 8, 2022 at 8:07 AM CST
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(Gray News) - The Food and Drug Administration has posted a voluntary recall of the Standard Q COVID-19 AG Home Test due to confirmed reports it was imported into the United States illegally.

According to the FDA, these tests are not authorized, cleared or approved for distribution or use in the United States.

SD Biosensor, Inc. is issuing the recall of its product out of an abundance of caution, though there is no known distribution of these tests directly to consumers.

Anyone who may potentially have one of these tests is encouraged to throw it away and use an FDA authorized test instead.

SD Biosensor has launched an investigation to determine how the product was illegally imported into the United States.

The company is also taking measures to prevent further attempts at illegal importation of unauthorized tests.

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