FDA Warns of Possible False Results From Some COVID-19 Tests

A doctor or Medtech shows rapid laboratory COVID-19 test to detect IgM and IgG antibodies to Novel Coronavirus, SARS-CoV-2 with a positive result. Immunity against Covid-19, respiratory viral pneumonia. (Anya Ivanova/Shutterstock)

The Epoch Times - By Jack Phillips, March 2, 2022

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 is 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.

The FDA said it has “not received reports of injuries, adverse health consequences, or death associated with the use of” any of the three tests.

In a statement, ACON Laboratories stated that the unauthorized tests are an “adulterated and misbranded counterfeit product.”

In February, the FDA issued warnings about the E25Bio COVID-19 Direct Antigen Rapid Test, the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test, and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test for similar reasons. Recalls were also initiated for the tests.

“The U.S. Food and Drug Administration (FDA) is warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test,” the health agency’s statement said at the time. “These tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States.”

It also comes as some poison control centers warning people not to improperly use at-home COVID-19 tests because they contain sodium azide, a potentially toxic substance. Some local poison control centers and hospitals have warned about an uptick in phone calls about exposures to the chemical.  Tests made by Flowflex and Celltrion contain the substance.

Jack Phillips is a breaking news reporter at The Epoch Times based in New York.

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