The Food and Drug Administration recently issued a warning to stop using Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.
“Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, and the FDA has identified this issue as a Class I recall, the most serious type of recall,” according to an FDA news release.
“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,” according to the press release.
The FDA emphasized its concerns about the increased likelihood of false results from an unauthorized test.
Test users and caregivers who used one of the tests should talk to their healthcare providers if they have concerns about their results, according to the FDA.
The agency said people should get re-tested if they used the CovClear COVID-19 Rapid Antigen Test less than two weeks.
If people were tested more than two weeks ago, there is no reason to re-test unless there is reason to suspect infection, according to the FDA.
If you used the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, get a re-test if you suspect a recent or prior infection, the FDA said.
The CovClear COVID-29 Rapid Anitgen Test uses a nasal swab to detect antigens. And the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test uses a fingerstick blood sample to detect antibodies.
A false-negative result of the antigen test says someone does not have COVID-19 when the person is indeed infected. According to the FDA, a false negative could lead to delayed diagnosis or inappropriate treatment, which could cause serious illness and even death.
And the agency said the false negatives could also cause the further spread of the virus.
A false negative says that the person does not have antibodies, when in fact they do.
The FDA encourages people to report any problems with the tests at www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.