Nearly 200,000 at-home COVID-19 tests in the United States have been recalled by Australian medical tech manufacturer Ellume after the company identified that they were producing incorrect positive results.
Ellume was given an emergency authorization in December 2020 by the U.S. Food and Drug Administration (FDA) to supply the COVID-19 Home Test for nonprescription use by symptomatic and asymptomatic individuals aged 2 years and older. The home tests deliver results within 15 minutes.