NEW YORK ─ The US Food and Drug Administration on Friday issued a warning telling people to stop using two tests produced by Empowered Diagnostics — its CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.
The Pompano Beach, Florida-based rapid test developer is recalling both tests, and the FDA has labeled the recall a Class I, the most serious type.
Though Empowered distributed the antigen and antibody tests with a label that indicated the FDA had authorized them, the agency had neither authorized, cleared, nor approved the assays for distribution or use in the US.
The FDA said it issued the warning because it is concerned about the risk of false results from unauthorized tests.
While the CovClear COVID-19 Rapid Antigen Test uses a nasal swab sample to detect SARS-CoV-2 antigens, the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test uses a fingerstick blood sample to detect antibodies produced by the immune system in response to SARS-CoV-2.
According to the FDA, test users and caregivers should talk to their healthcare provider if they took a CovClear COVID-19 Rapid Antigen Test and have concerns about the results. Further, healthcare providers and testing program organizers should consider retesting patients using an FDA authorized SARS-CoV-2 diagnostic test if they suspect an inaccurate result and if the test was taken less than two weeks ago. If the test was taken more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest, the FDA said.
Meanwhile, test users and caregivers who have concerns about test results after taking an ImmunoPass COVID-19 Neutralizing Antibody Rapid Test should talk to their healthcare providers, the agency said. Healthcare providers and testing program organizers should consider retesting patients using an FDA authorized SARS-CoV-2 antibody test if they suspect a recent or prior COVID-19 infection.
The FDA said it is working with Empowered to resolve issues related to the recall.