03/26/2024: Lab Alert: FDA Revokes EUAs for Six SARS-CoV-2 In Vitro Diagnostic Devices

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Individuals Performing COVID-19 Testing

Level: Laboratory Alert

On March 21, 2024, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register about the revocation of six Emergency Use Authorizations (EUAs) of in vitro diagnostic devices for detection and/or diagnosis of COVID-19 to:

  • Life Technologies Corp. (a legal entity of Thermo Fisher Scientific, Inc.), for the TaqPath COVID-19 Pooling Kit
  • Bio-Rad Laboratories, Inc., for the Reliance SARS-CoV-2 RT-PCR Assay Kit
  • Revvity, Inc., (on behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding of PerkinElmer Genomics)), for the PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit
  • bioMérieux SA, for the VIDAS SARS-CoV-2 IgM kit
  • bioMérieux SA, for the VIDAS SARS-CoV-2 IgG kit
  • Luminex Corp., for the xMAP SARS-CoV-2 Multi-Antigen IgG Assay

FDA revoked these EUAs under the authority of the Federal Food, Drug, and Cosmetic Act. Refer to the FDA Letter of Revocation for more information.

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Thank you,

The Laboratory Outreach Communication System

Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)

Center for Laboratory Systems and Response (CLSR)

Centers for Disease Control and Prevention (CDC)