2 Types Of Rapid COVID Tests Recalled; Were Never Authorized By The FDA
LOS ANGELES (CBSLA) — A recall has been issued for two types of rapid COVID-19 tests that were never authorized for use by the FDA.
A Class I recall, the FDA's most series type of recall, was issued for Empowered CovClear COVID-19 Rapid Antigen tests and ImmunoPass COVID-19 Neutralizing Antibody Rapid tests. The CovClear test uses a nasal swab, but the ImmunoPass test uses a fingerstick blood sample.
"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," a statement from the FDA said.
Consumers who have used either of these tests should talk to their health providers if they have concerns about their test results. The FDA says healthcare providers and testing program organizers should consider retesting their patients using an FDA-authorized SARS-CoV-2 antibody test if an inaccurate result is suspected.
To report any potential problem with a COVID test, visit the FDA's MedWatch Voluntary Reporting Form.
High demand for COVID testing has given way to a slew of suspicious tests and test sites. California Attorney General Rob Bonta issued an alert last week that consumers should seek out legitimate testing sites, or request free at-home tests from their respective counties or the federal government.