GRAND RAPIDS, Mich. (WOOD) — The Food and Drug Administration has issued a recall for more than a quarter-million COVID-19 rapid antigen tests.
The recall is for the CovClear Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. The recall covers all lot codes and any test distributed between Jan. 1, 2021 and Nov. 11, 2021.
FDA officials say the test falsely states that the product is FDA approved and could have an unacceptable rate of false results. The tests, produced by Empowered Diagnostics in Florida, have been approved for at-home use by health departments in Canada and the European Union.
Empowered Diagnostics claims its rapid tests are 95.5% accurate, using a nasal swab to confirm the presence of the SARS-CoV-2 nucleocapsid protein.
Anyone that has one of the recalled tests is encouraged to reach out to Empowered Diagnostics for refund instructions.