Revocation of EUA210196, Lucira CHECK-IT COVID-19 Test Kit — Pfizer Inc. (April 2, 2025)

Summary

A letter dated April 2, 2025 from the U.S. Food and Drug Administration to Pfizer Inc. revoking EUA210196 for the Lucira CHECK-IT COVID-19 Test Kit. It responds to Pfizer's request in a letter dated March 14, 2025, and recites that the EUA was issued on April 9, 2021 and later amended and reissued. The letter states that Pfizer indicated it did not distribute the authorized product and that FDA understands no viable test kit reagents are in distribution in the United States. Citing section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3), FDA revokes the authorization and states that notice will be published in the Federal Register. It closes with the signature block of Ellen J. Flannery, Deputy Center Director for Policy, Center for Devices and Radiological Health.

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Full text

                                           April 2, 2025

Elizabeth Mauro
Director, Global Regulatory Science
Pfizer Inc.
66 Hudson Boulevard East
New York, NY 10001
Re: Revocation of EUA210196

Dear Elizabeth Mauro:
This letter is in response to the request from Pfizer Inc., in letter dated March 14, 2025, that the
U.S. Food and Drug Administration (FDA) revoke the EUA for the Lucira CHECK-IT COVID-
19 Test Kit issued on April 9, 2021, amended on September 23, 2021, July 28, 2022, and
December 12, 2022, and revised and reissued on June 29, 2023. Pfizer Inc. indicated that they
did not distribute the authorized product and requested that the EUA be revoked. FDA
understands that as of the date of this letter there are no viable Lucira CHECK-IT COVID-19
Test Kit reagents in distribution in the United States.

The authorization of a device for emergency use under section 564 of the Federal Food, Drug,
and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,
be revoked when circumstances make such revocation appropriate to protect the public health or
safety (section 564(g)(2)(C) of the Act). Because Pfizer Inc. has requested that FDA revoke the
EUA for the Lucira CHECK-IT COVID-19 Test Kit, FDA has determined that it is appropriate
to protect the public health or safety to revoke this authorization. Accordingly, FDA hereby
revokes EUA210196 for the Lucira CHECK-IT COVID-19 Test Kit, pursuant to section
564(g)(2)(C) of the Act. As of the date of this letter, the Lucira CHECK-IT COVID-19 Test Kit
is no longer authorized for emergency use by FDA.

Notice of this revocation will be published in the Federal Register, pursuant to section 564(h)(1)
of the Act.

                                              Sincerely,



                                              __________________________
                                              Ellen J. Flannery, J.D.
                                              Deputy Center Director for Policy
                                              Director, Office of Policy
                                              Center for Devices and Radiological Health
                                              Food and Drug Administration


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FDA_Lucira-CHECK-IT_EUA-REVOCATION-Letter.pdf

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www.fda.gov