What Should You Do if You Used an Ellume Test? The Food and Drug Administration has vastly expanded the recall of Ellume at home COVID-19 testing kits over false postive results, now classifying it as its most serious type of recall. Grace holds a dual degree in journalism and science in human cultures from Northwestern University with a concentration in environment, science, and society. The FDA approved the tests for use under an emergency use authorization in December 2020. In February, the Biden administration announced a $231.8 million award for Ellume USA for production of its at-home tests for the US. A list of the affected lot numbers can be found at the Medical Device Recall Database Entry. All information these cookies collect is aggregated and therefore anonymous. The recall, however, does not affect ACON Laboratories' Flowflex COVID-19 Antigen Home Test, which is authorized for use in the US by the FDA. Ellume did not say what percentage were false positives. You can review and change the way we collect information below. More than 2.2 million tests had been distributed between April 13, 2021, and August 26, 2021, and there were 35 reports of false positive tests, according to the FDA. Ellume is now working with the FDA to remove the affected tests from the market, which were sent to retailers and distributors between April and August 2021. Ellume home COVID test recall: False positives blamed for recall Cost to taxpayers: AU $50m US $230m Can we get a refund please? Ellume So when opportunity knocks Aspen Medical. At-Home Flu Tests Are Surprisingly AccurateSo Why Don't We Have One Yet? NOW WATCH: Here's what happens after you call 911 for the coronavirus. U.S. Food & Drug Administration. Ellume has expanded its recall of rapid at-home COVID-19 antigen tests to about 2 million tests, the Food and Drug Administration said in an update this week. Information relating to the action to be taken by distributors and retailers for the affected lots is also provided on the companys website. Test Recall Thats also troublesome. If they have received a positive test result, this result may be incorrect and they should contact a healthcare professional immediately and notify them of this recall and ask to obtain a confirmatory test (i.e., molecular or RT-PCR).
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