COVID-19 Rapid Test Recall: These Brands Give False Positives

The Food and Drug Administration issued a warning Friday to stop using the COVID-19 rapid antigen test Empowered Diagnostics CovClear and the neutralizing antibody rapid test ImmunoPass. These tests are being distributed in the U.S. with labels that show the FDA authorized them, which they did not. The FDA has concerns about the potential risk of false positives when using COVID-19 tests are not approved. They have classified the two tests as a Class I recall, which is the most serious type of recall. "These tests were distributed with labeling showing the FDA authorized them, but neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the potentially higher risk of false results when using unauthorized tests," read an FDA press release.