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FDA Recalls 2 Million At-Home COVID Tests From Australia's Ellume Because of 'False Positives'
https://www.thedailybeast.com/fda-recalls-2-million-at-home-covid-tests-from-australias-ellume-because-of-false-positivesThe U.S. Food and Drug Administration has recalled some 2 million at-home COVID tests because of a manufacturing fault that can produce “false positive” results. The nasal swab tests, which can be bought over the counter, are manufactured by the Australian-based company Ellume under a deal with the U.S. government.
So far, 35 false positives have been reported to the FDA, prompting the Category 1 recall—which the agency called “the most serious type.” Earlier this year, Ellume signed a $231.8 million deal to provide the tests, allowing the biotech to open a plant in Maryland. The White House last month committed an additional $1 billion to help overcome a national shortage of at-home tests, which experts say are a crucial tool in containing the coronavirus.
So far, 35 false positives have been reported to the FDA, prompting the Category 1 recall—which the agency called “the most serious type.” Earlier this year, Ellume signed a $231.8 million deal to provide the tests, allowing the biotech to open a plant in Maryland. The White House last month committed an additional $1 billion to help overcome a national shortage of at-home tests, which experts say are a crucial tool in containing the coronavirus.
https://www.npr.org/2021/11/11/1054606822/fda-recalling-2-million-ellume-at-home-covid-19-test-kits-because-of-false-posit?t=1636629372410