The U.S. Food and Drug Administration (FDA) on Tuesday said that three rapid COVID-19 tests should not be used because of the potential for producing false results.
The FDA told people to stop using the Celltrion DiaTrust COVID-19 Ag Rapid Test, the SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test, and the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).
“The FDA is concerned about the risk of false results when using” those tests, according to the agency. These tests have “not been authorized, cleared or approved by the FDA for distribution or use in the United States,” the agency added.
All three tests work via nasal swab, the agency said. It recommended that health care providers have patients submit to new testing if they’ve used any of the three tests fewer than two weeks ago.
The FDA said ACON Laboratories has recalled all of its Flowflex tests, SD Biosensor has recalled its tests, and Celltrion USA has recalled all of its DiaTrust tests.
“People should not use the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white packaging,” the FDA said, including a photo of the test.
SD Biosensor’s “unauthorized test may be packaged in a white and magenta box,” the FDA said.
And the ACON Laboratories tests are packaged in a dark blue box, according to the agency.
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