Ellume issues recall of test for SARS-CoV-2 infection

By LabPulse.com staff writers

November 10, 2021 -- Ellume is recalling its COVID-19 Home Test for detecting SARS-CoV-2 infection due to its potential to produce false-positive results, according to the U.S. Food and Drug Administration (FDA).

The move comes in response to a safety communication the FDA released October 5. The recall is categorized as class I, the most serious type, the FDA said. Total affected tests are approximately 2 million.

The FDA issued emergency use authorization for the test in December 2020. It is working with Ellume to determine what corrective actions the company should take.

FDA issues alert on Ellume at-home COVID-19 tests
Some home tests for COVID-19 manufactured by Ellume may deliver false-positive results due to a manufacturing issue, according to a safety communication...
FDA issues EUA for Ellume's at-home COVID-19 test
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for an over-the-counter at-home diagnostic test for COVID-19...

Copyright © 2021 LabPulse.com

Last Updated ls 11/10/2021 4:06:52 PM



Subscribe Today
Do you want to be a Microbiology Insider?

When LabPulse gets hot new information, our Insiders are the first to find out. Stay current in today's competitive market by receiving our exclusive free email updates.

Yes, Keep Me Current