Ellume COVID-19 Home Test

Date: 01/10/2021

Product Names: Ellume COVID-19 Home Test
Product Codes and Lot Numbers: See Medical Device Recall Database Entries or the Ellume Recall Website below in the Additional Resources section
Manufacturing Dates: February 24, 2021 to August 11, 2021
Distribution Dates: April 13, 2021 to August 26, 2021
Devices Recalled in the United States: 2,212,335
Date Initiated by Firm: October 1, 2021

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/ellume-recalls-covid-19-home-test-potential-false-positive-sars-cov-2-test-results