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 years and older. The home tests deliver results within 15 minutes. The Biden administration signed a $231.8 million deal with the company, which initially got the green light from the Trump administration last year, to produce to over 633,000 tests kits per day (19 million per month), of which 8.5 million units were reserved for Americans. But the FDA on Tuesday said it is “alerting test users, caregivers, health care personnel, and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test, due to a recently identified manufacturing issue.” “For …
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