FDA Revokes Emergency Use Authorizations for Three Beckman Coulter COVID-19 Tests
March 20, 2025
March 20, 2025
WASHINGTON, March 20 (TNSFR) -- The Food and Drug Administration (FDA) has revoked the Emergency Use Authorizations (EUAs) for three COVID-19 in vitro diagnostic tests manufactured by Beckman Coulter, Inc. The affected tests include the Access SARS-CoV-2 IgG, Access SARS-CoV-2 IgM, and Access SARS-CoV-2 IgG II. The agency made this decision following a request from Beckman Coulter, which sought the revocations as part of its plan to discontinue the distribution of these tests. The revocations be . . .