While we’re all trying to comply with frequent COVID-19 testing recommendations, and buying up test kits as quickly as stores can stock them, it’s also good to pause and remember that wherever there’s an opportunity, overly-zealous and sometimes downright fraudulent operators will try to get in on the profit potential. Unfortunately, on Friday, January 28, the U.S. Food and Drug Association issued a recall notice for two COVID-19 rapid antigen test kits the agency says “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 main concern with the sale of unauthorized tests, the FDA says, is “the potentially higher risk of false results.”
The two tests the FDA is warning people to stop using are the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test (a nasal swab test) and the Immuno Pass COVID-19 Neutralizing Antibody Rapid Test (which uses a finger-stick/blood sample to test for COVID-19 antibodies).
As of this morning, the Empowered Diagnostics website (see product links above), says the the first test is “authorized in Canada for OTC use at home and other non-laboratory sites,” and “has CE marking in the European Union for Point-of-Care Use,” but is “NOT available for sale or distribution in the United States.” The page for the second product says simply that it “is not available for sale or distribution in the United States.”
According to the FDA, the agency “has identified this issue as a Class I recall, the most serious type of recall,” and warns, “Do not use the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test,” due to the potential for false results.
If you have recently used either of these test kits, the FDA recommends talking to your health care provider, and possibly re-testing with a different product. Health care providers who have used the tests in the last two weeks are advised to contact and potentially re-test those patients. False negative results are potentially dangerous, says the FDA, because they “may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause people harm including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when people are housed together in health care, long-term care, and other facilities based on these false test results.”
The FDA says it is “working with Empowered Diagnostics to resolve these issues” and will provide new information when available. In the meantime, questions can be directed to the FDA’s Division of Industry and Consumer Education (DICE) at [email protected] or (800) 638-2041 or (301) 796-7100.
