We have been discussing testing for Covid-19 for a long time.  From the lack of testing available to the fake Covid-19 testing being sold on the internet, to people in the medical field informing us that a negative result from approved at-home tests kits might not actually mean you have not contracted the virus.

On January 3, 2022, I wrote a piece about the difficult journey my wife and I had in finding a Covid-19 test during the last holidays.

Then on January 11, 2022, I wrote another piece warning people of the fake Covid-19 tests being sold online and what you should do to avoid those fake tests.

On January 19, 2022, I wrote another piece about doctors, pharmacists and scientists that state the rapid tests the government is sending out to anyone who requests them may not be accurate enough to really help.  We are now being told that a negative test result for Covid-19 might not actually mean you do not have Covid-19.

Now the FDA through a January 28, 2022 press release has recommended that no one use the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.

The press release states:

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. The FDA is concerned about the potentially higher risk of false results when using unauthorized tests.

What if you have already taken one of those at-home antigen tests, what should you do?  According to the FDA:

  • "Test users and caregivers: Talk to your health care provider if you were tested with the CovClear COVID-19 Rapid Antigen Test and you have concerns about your test results.
  • Health care providers and testing program organizers: If the antigen test was given less than two weeks ago, consider retesting your patients using an FDA authorized SARS-CoV-2 diagnostic test if you suspect an inaccurate result. If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.
  • Report any problems you experience with the CovClear COVID-19 Rapid Antigen Test to the FDA, including suspected false results. See Reporting Problems with Your Test."

Be careful with what tests you do use and verify that they are genuinely FDA authorized, never trust the labeling alone.

The FDA informs us that they have classified the recall for these tests as a Class I recall, the most serious type of recall.  The press release stated that the FDA is working with the companies involved to “resolve these issues”.

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