Type:Notice
Citation:90 FR 13164
Reading Time:about 4 minutes
The Food and Drug Administration (FDA) has announced the revocation of Emergency Use Authorizations (EUAs) for three COVID-19 tests developed by Beckman Coulter, Inc., including the Access SARS-CoV-2 IgG, IgM, and IgG II tests. This action was taken upon the request of Beckman Coulter, who also decided to stop the distribution of these tests as of January 1, 2025. The FDA concluded that revoking these authorizations is necessary to protect public health and safety. The revocation became effective on January 8, 2025, with detailed explanations provided for each decision.
Simple Explanation
The FDA has stopped the use of three COVID-19 tests from a company called Beckman Coulter because the company asked them to, and it's to keep people safe.