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The Food and Drug Administration (FDA) issued a warning about using the “Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test” and “ImmunoPass COVID-19 Neutralizing Antibody Rapid Test” due to mislabeling.
According to authorities, the tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved for distribution or use in the US.
Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, the FDA said, noting that it is a Class I recall.
A Class I recall is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death,” according to the FDA.
The FDA said that anyone who was tested using either of the recalled tests should talk to a health care provider if they are concerned with the results.
"A false-negative result may lead to delayed diagnosis or inappropriate treatment of (COVID-19), which may cause people harm including serious illness and death,” officials said. “False-negative results can also lead to further spread of (COVID-19), including when people are housed together in health care, long-term care, and other facilities based on these false test results.”
Officials said that a false-positive test “may lead to a delay in both the correct diagnosis and appropriate treatment for the actual cause of a person’s illness, which could be another life-threatening disease that is not COVID-19.”
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