The U.S. Food and Drug Administration (FDA) has issued a warning about two more COVID-19 tests that have been recalled. The two new recalled tests are in addition to two brands that have previously been recalled. Here’s what you need to know.
What Two COVID-19 Tests Got Recalled and Why?
On January 28, 2022, the FDA issued a recall for the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. According to the detailed release, the two newly recalled tests were distributed with a label that indicated they were authorized by the FDA. However, neither had been cleared, approved, or authorized for distribution in the United States.
“The FDA is concerned about the potentially higher risk of false results when using unauthorized tests,” the release states. The FDA has categorized these two recalls as “Class I” which is the most serious type of recall for “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.”
Here’s Why You Need to Stop Using Them Immediately
With neither test being FDA approved, and yet labeled as such, the concern is the high likeliness of a false result, whether a false positive or false negative. Obviously, a false positive could make someone isolate, pull their kids out of school, or have to notify close contacts of a positive test that doesn’t truly exist. A false negative could lead a positive person to behave as though they weren’t sick, going back to work, walking into stores, and being in close contact with others.
In particular, the “FDA is concerned about the potentially higher risk of false results when using unauthorized tests,” the recall notice reads.
The agency is strongly recommending that people don’t use either Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. Anyone who previously tested with either rapid test is urged to speak with their care provider. Throw out the faulty tests.
Anyone concerned about a potentially faulty test — especially if it’s a not-already officially recalled test brand — is encouraged to file a report through the FDA’s MedWatch Voluntary Reporting Form.
The FDA is reminding people of the importance of using a COVID-19 rapid test that’s approved. These are ones that have undergone the agency’s strict testing process and the results have been proven reliable. If you’re not sure if the test you have is approved by the agency, be sure to cross-check the FDA’s list of 45 different COVID-19 antibody tests.