Empowered Diagnostics Recalls COVID-19 Tests due to Risk of False Results

Date: 01/28/2022

Product type: Medical Devices

Empowered Diagnostics, LLC CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test
All lot codes
Distribution Dates: January 1, 2021 to November 11, 2021
Devices Recalled in the U.S.: At least 284,575 antigen tests
At least 2,100 antibody tests
Date Recall Initiated by Firm: December 22, 2021

USA-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/empowered-diagnostics-recalls-covid-19-tests-due-risk-false-results