Category: false positive

Ellume’s COVID-19 Home Test Recall Most Serious, FDA Says

November 10, 2021
AMERICAAustraliaCCP VirusCOVID-19false positiveInternationalPUBLIC HEALTH INFORMATIONrecallUSUS NewsWorld
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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…

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Australian Medical Manufacturer Recalls Nearly 200,000 COVID-19 Tests in US Over ‘False Positive’ Results

October 6, 2021
AMERICAAustraliaBusiness & EconomyCCP VirusCompaniesCOVID-19Department of DefenseEllume COVID home testfalse positiveInternationalPUBLIC HEALTH INFORMATIONUSUS NewsWorld
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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 produced an incorrect positive result. Ellume was given an emergency authorization in December by the U.S. Food and Drug Administration (FDA) to supply the COVID-19 Home Test for non-prescription use by symptomatic and asymptomatic individuals aged 2…

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