covid tests

What to Know: FDA Issues Warnings About 3 At-Home COVID Tests That Could Pose Risk of ‘False Results'

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The Food and Drug Administration has issued warnings to the public about three different at-home COVID-19 tests, saying that the testing kits have not been authorized by the FDA and that they could pose a risk of false results.

According to a series of press releases, the FDA has warned Americans not to use certain tests from three different companies:

ACON Laboratories “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)”

This test is packaged in a dark-blue box, and has not been authorized, cleared or approved by the FDA for distribution and use in the United States.

While the FDA says there have been no injuries or adverse health consequences reported, they are concerned about the risk of false results when using the test.

ACON Laboratories has issued a recall for all unauthorized tests that were distributed in the United States.

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SD Biosensor Inc. “STANDARD Q COVID-19 Ag Home Test”

This test may be packaged in a white and magenta box, and FDA officials say they are concerned about the risk of false results when using the test.

No injuries or adverse health consequences have been reported due to this test.

Celltrion DiaTrust “COVID-19 Ag Rapid Test”

This test comes in green and white packaging, and has not been approved for use by the FDA. No reports of adverse health consequences have been received by federal health officials.

This test poses a bit of a trickier situation for consumers, as it shares the name as an FDA-approved version of the test for point-of-care settings, but officials warn that it is NOT the same test.

The green-and-white packaged tests are not authorized by the FDA. The “COVID-19 Ag Home Test” from the company was authorized by the FDA for at-home use. The approved test comes in blue and white packaging.

The company has issued a recall for all unauthorized tests that were distributed in the United States, with at least 162,000 unauthorized tests having been sent to retailers and other outlets.

What You, or Your Health Care Provider, Can Do Now

If you think you had a problem with a COVID-19 test, the FDA encourages Americans to report problems through the MedWatch Voluntary Reporting Form, which you can find at the hyperlink.

Americans are also advised to talk to their health care providers if they think they took one of the three tests, and if they have concerns about their test results.

Health care providers are urged to re-test patients if they had been tested with the unauthorized kits. If the test occurred more than two weeks ago, and there is no reason to suspect a current COVID-19 case, then a new test is not necessary.

If residents or health care providers have any further questions, they can email the Division of Industry and Consumer Education at DICE@FDA.HHS.GOV, or call 800-638-2041.

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