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

by Mike Robinson

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© Reuters. FILE PHOTO – Signage outside the Food and Drug Administration headquarters in White Oak (Maryland, U.S.A), August 29, 2020. REUTERS/Andrew Kelly/File photo

(Reuters) – The U.S. Food and Drug Administration categorized the recall of Ellume’s COVID-19 home tests as Class 1 after it was removed from the marketplace by an Australian diagnostic testing company.

Ellume had cited higher-than-acceptable false positive test results for SARS-CoV-2 as the reason for the recall.

If a false positive is reported, it means that the person may have the virus but not actually have it.

For people over two years old with COVID-19 symptoms or not, the antigen test can be performed without prescription. It detects proteins in the SARS/CoV-2 virus using a nasal sample.

According to the agency, there were 35 reports of false positive antigen results from the testing on Wednesday. However, no deaths have been reported.

Ellume has sofar recalled 221,335 American tests.

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