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Ellume's COVID-19 home test recall most serious, FDA says

The U.S. Food and Drug Administration classified the recall of Ellume's over-the-counter COVID-19 home test as Class 1, the most serious type of recall, after the Australian diagnostic test maker removed some of its tests from the market last month. Ellume had cited higher-than-acceptable false positive test results for SARS-CoV-2 as the reason for the recall. A 'false positive' indicates that a person has the virus when they actually do not.

Reuters - November 11, 2021

View the full story here: https://www.reuters.com/world/us/ellumes-covid-19-home-test-recall-most-serious-fda-says-2021-11-10/