Free Republic

The U.S. Food and Drug Administration (FDA) confirmed Thursday it is recalling some 2 million Ellume at-home COVID-19 testing because they can produce “false positives” due to a manufacturing defect.The firm first informed the federal regulatory agency about the defect in some lots in October. But on Wednesday, the FDA said it identified additional lots that were affected by the manufacturing defect, made between Feb. 24, 2021, and Aug. 11, 2021.To date, about 35 false positives from the COVID-19 tests were reported to the FDA. No deaths have been reported related to the test, according to the agency.A “false positive”...

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...

The FDA on Tuesday approved the first over-the-counter COVID-19 test involving a nasal swab — and near-instant results. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,’’ said Stephen Hahn, commissioner of the Food and Drug Administration, in a statement on the agency’s website.