FDA issues warning about another coronavirus at-home test – SILive.com

STATEN ISLAND, N.Y. The U.S. Food and Drug Administration (FDA) is warning people to not use certain Flowflex coronavirus (COVID-19) rapid tests, because there is a risk of false results.

The FDA said people should avoid using the Acon Laboratories test named Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) that is packaged in a dark blue box, as it has not been authorized, cleared, or approved by the FDA for distribution or use in the United States.

The agency hasnt received reports of injuries, adverse health consequences, or death associated with the use of this rapid at-home test.

If you have a Flowflex COVID-19 rapid test, you should compare the packaging to the photo above, and shouldnt use it if its in a dark blue box.

The unauthorized test uses a nasal swab sample to detect proteins, called antigens, from SARS-CoV-2, the virus that causes COVID-19. The unauthorized test has a dark blue box with white lettering and symbols in the lower right corner of the box, including the letters CE.

It is important to note that the Acon Laboratories Flowflex COVID-19 Antigen Home Test, in white packaging, was authorized by the FDA in October 2021 and can continue to be used.

Here is a list of at-home tests authorized by the FDA.

A false-negative antigen test result means that the test says the person doesnt have COVID-19, but they actually do have the virus. A false-negative result may lead to delayed diagnosis or inappropriate treatment, which may cause people harm -- including serious illness and death. It can also lead to further spread of COVID-19.

A false-positive antigen test result means that the test says the person has COVID-19 but they actually do not have it. This may lead to a delay in both the correct diagnosis and appropriate treatment for the actual cause of a persons illness, which could be another life-threatening disease that is not COVID-19.

ACON Laboratories Inc. has initiated a recall for all unauthorized Flowflex SARS-CoV-2 Antigen Rapid Tests tests that were distributed in the United States.

Talk to your health-care provider if you think you were tested with the rapid test and you have concerns about your results. Consider retesting using an authorized test if you suspect an inaccurate result.

If you think you had a problem with a COVID-19 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

OTHER PROBLEMATIC RAPID TESTS

Last month, a South Korean company recalled a coronavirus rapid test kit because it was illegally imported into the United States. SD Biosensor Inc. recalled its Standard Q COVID-19 Ag Home Test that is not authorized, cleared, or approved by the FDA for distribution or use in the United States.

While there is no known distribution of these tests directly to consumers, the company is issuing the recall out of an abundance of caution.

In January, the FDA said to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.

These tests were distributed with labeling that indicates they are authorized by the FDA but the agency said neither test has been authorized, cleared, or approved for distribution or use in the United States.

The agency said its concerned about the potentially higher risk of false results when using unauthorized tests.

Therefore, Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. The FDA identified this as a Class I recall, the most serious type of recall.

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FDA issues warning about another coronavirus at-home test - SILive.com