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FDA warns against use of two COVID-19 tests

By Natalie Dreier, Cox Media Group National Content Desk
By Natalie Dreier, Cox Media Group National Content Desk

The Food and Drug Administration is warning against the use of two more at-home COVID-19 tests.

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The FDA is saying that people should not use the Celltrion USA Inc. DiaTrust COVID-19 Ag Rapid Test in green-and-white packaging.

FDA warning The FDA has issued a safety warning concerning two COVID-19 tests. (FDA.gov)

The test was not “authorized, cleared or approved by the FDA for distribution or use in the United States.”

The FDA said the tests could produce a false result, but there have not been any reports of any injuries or adverse health consequences.

A similar product, the Celltrion DiaTrust COVID-19 AGg Home Test has been approved by the FDA and is not subject to the alert, meaning it can still be used.

The FDA has also warned against the use of the SD Biosensor Inc. Standard Q COVID-19 AG Home Test.

The FDA said that test is also not authorized for use in the U.S. and could lead to false results.

The test is packaged in a white and magenta box.

FDA warning The FDA has issued a safety warning concerning two COVID-19 tests. (FDA.gov)

A similarly named test, the SD Biosensor COVID-19 At-Home Test has been authorized and is not subject to the safety alert.

Related coverage:

• FDA warns against E25Bio COVID-19 tests

• Coronavirus: FDA releases updated list of authorized at home COVID-19 tests

• FDA: Stop using LuSys Laboratories COVID-19 tests due to potential false results

• Coronavirus: False result fears prompt recall of nearly 300K rapid COVID-19 tests

• FDA announces voluntary recall of SD Biosensor, Inc. Standard Q COVID-19 at-home tests


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