FDA Axes Three COVID Antibody Tests: Time to Switch
Published Date: 3/20/2025
Notice
Summary
The FDA is officially ending the emergency use permissions for three COVID-19 antibody tests made by Beckman Coulter, Inc. This change affects anyone using these specific tests, and it’s happening because the company asked for it. If you’re using these tests, be ready to switch to other options soon—no extra costs from the FDA side, just a heads-up to update your tools.
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
Three Beckman Antibody EUAs Revoked
The FDA revoked the Emergency Use Authorizations for three Beckman Coulter antibody tests: Access SARS-CoV-2 IgG, Access SARS-CoV-2 IgM, and Access SARS-CoV-2 IgG II. If you use these specific tests, you will need to switch to other testing options soon; the revocations were made at the request of Beckman Coulter, Inc., and the FDA states there are no additional costs from the FDA side.
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