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FDA Recalls 2 Million At-Home COVID Tests From Australia’s Ellume Because of ‘False Positives’

Officials say that at-home tests made by Australian-based Ellume have so far produced about 35 false positive results

The 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.