MORE AT-HOME TESTS MAY BE FAULTY

The U.S. Food & Drug Administration is warning people to stop using certain COVID-19 Antigen Tests because after evaluating the tests,  the FDA believes that it's likely there is a high risk of false results. The tests in question have not been authorized by the FDA for use in the United States.  The FDA thinks that the tests were distributed for use in laboratories or for at-home testing.

The tests in question are as follows:

  • The LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva)
  • The COVID-19 IgG/IgM Antibody Test was sold under the company names Luscient Diagnostics and Vivera Pharmaceuticals. They may also have the trade name EagleDx.

If you believe you took one of these tests and your results came back negative or positive, you may want to be retested.

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RETESTING IS IMPORTANT AND HERE'S WHY

It may not seem like a big deal to be retested if you've used one of these tests, but actually, it can cause test users who get a false negative to go back to work too soon, infecting others. A false positive could cause the individual to miss work when they may really need the paycheck.

REPORT PROBLEMS WITH YOUR AT-HOME TESTS

If you think you had a problem with an at-home test the FDA would like you to contact them. For example, maybe you took an at-home test and tested negative, but then went to a testing site and tested positive. Also if you think you had issues with the testing device, they would like you to inform them and fill out the MedWatch Voluntary Reporting Form, which you can get a copy of by clicking here.

 

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