{"id":998969,"date":"2021-11-11T13:44:40","date_gmt":"2021-11-11T18:44:40","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=998969"},"modified":"2021-11-11T13:44:45","modified_gmt":"2021-11-11T18:44:45","slug":"over-2-million-at-home-covid-tests-recalled-over-false-positives","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/over-2-million-at-home-covid-tests-recalled-over-false-positives\/","title":{"rendered":"Over 2 Million At-Home COVID Tests Recalled Over False Positives"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"&quot;\"><div class=\"counts mashsbcount\">20<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Fover-2-million-at-home-covid-tests-recalled-over-false-positives%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=998969&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47--><p class=\"p1\">The Australian medical technology company Ellume has recalled over 2 million of its at-home COVID-19 tests over potential false positives.<\/p>\n<p>The recall, defined by the FDA as Class I, is \u201cthe most serious\u201d of the types of recalls. \u201cUse of these tests may cause serious adverse health consequences or death,\u201d the FDA notes.<\/p>\n<p class=\"p1\">The test, according to the FDA, \u201cdetects proteins from the SARS-CoV-2 virus from a nasal sample in people two years of age or older.\u201d It \u201cis available without a prescription for use by people with or without COVID-19 symptoms\u201d and \u201cuses an analyzer that connects with a smartphone app to show users how to perform the test and understand the test results.\u201d<\/p>\n<p>A spokesperson for Ellume told The New York Times the root cause of the problem has been identified.<\/p>\n<p class=\"p1\">\u201cEllume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.,\u201d said a spokesperson.&nbsp;\u201cImportantly, not all of the positive results of the affected tests were false positives, and negative results were not affected by this issue.\u201d<\/p>\n<p class=\"p1\">As <a href=\"https:\/\/www.npr.org\/2021\/11\/11\/1054606822\/fda-recalling-2-million-ellume-at-home-covid-19-test-kits-because-of-false-posit\">reported<\/a> by NPR, \u201cThe company first informed the FDA about the defect in some lots in October. On Wednesday, the FDA said it had identified additional lots that have been affected by the manufacturing defect.\u201d<\/p>\n<p class=\"p1\">Last month, Dr. Sean Parsons, the company\u2019s chief executive, <a href=\"https:\/\/www.nytimes.com\/2021\/11\/10\/health\/home-covid-test-kits.html\">said<\/a> that the company had created more measures to stop the problem from happening again.<\/p>\n<p class=\"p1\">\u201cI\u2019m very sorry that this has happened,\u201d he said. \u201cWe\u2019re all about chasing accuracy, and to have these false positives is disappointing.\u201d<\/p>\n<p class=\"p1\">The FDA described the reason for the recall, stating:<\/p>\n<p class=\"p1\">Ellume is recalling certain lots of the COVID-19 Home Test because they have higher-than-acceptable false positive test results for SARS-CoV-2. The reliability of negative test results is not affected. For these tests, a false positive test result shows that a person has the virus when they do not have it and could lead to:<\/p>\n<p>Delayed diagnosis or treatment for the actual cause of the person\u2019s illness, which could be another life-threatening disease that is not COVID-19.Further spread of the SARS-CoV-2 virus when presumed positive people are grouped into cohorts (that is, they are housed together) based on false test results.The person receiving unnecessary COVID-19 treatment from a health care provider, such as antiviral treatment, convalescent plasma, or monoclonal antibody treatment, which can result in side effects.Disregard for the recommended precautions against COVID-19, including vaccination.Isolation, including monitoring household<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Australian medical technology company Ellume has recalled over 2 million of its at-home COVID-19 tests over potential false positives.The recall, defined by the FDA as Class I, is \u201cthe most serious\u201d of the types of recalls. \u201cUse of these tests may cause serious adverse health consequences or death,\u201d the FDA notes.The test, according to the FDA, \u201cdetects proteins from the SARS-CoV-2 virus from a nasal sample in people two years of age or older.\u201d It \u201cis available without a prescription for use by people with or without COVID-19 symptoms\u201d and \u201cuses an analyzer that connects with a smartphone app to show users how to perform the test and understand the test results.\u201dA spokesperson for Ellume told The New York Times the root cause of the problem has been identified.\u201cEllume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.,\u201d said a spokesperson.\u00a0\u201cImportantly, not all of the positive results of the affected tests were false positives, and negative results were not affected by this issue.\u201dAs reported by NPR, \u201cThe company first informed the FDA about the defect in some lots in October. On Wednesday, the FDA said it had identified additional lots that have been affected by the manufacturing defect.\u201dLast month, Dr. Sean Parsons, the company\u2019s chief executive, said that the company had created more measures to stop the problem from happening again.\u201cI\u2019m very sorry that this has happened,\u201d he said. \u201cWe\u2019re all about chasing accuracy, and to have these false positives is disappointing.\u201dThe FDA described the reason for the recall, stating:Ellume is recalling certain lots of the COVID-19 Home Test because they have higher-than-acceptable false positive test results for SARS-CoV-2. The reliability of negative test results is not affected. For these tests, a false positive test result shows that a person has the virus when they do not have it and could lead to:Delayed diagnosis or treatment for the actual cause of the person\u2019s illness, which could be another life-threatening disease that is not COVID-19.Further spread of the SARS-CoV-2 virus when presumed positive people are grouped into cohorts (that is, they are housed together) based on false test results.The person receiving unnecessary COVID-19 treatment from a health care provider, such as antiviral treatment, convalescent plasma, or monoclonal antibody treatment, which can result in side effects.Disregard for the recommended precautions against COVID-19, including vaccination.Isolation, including monitoring household or close contacts for symptoms, limiting contact with family or friends, and missing school or work.There have reportedly been 35 cases reported where the devices showed a false positive, but it is unknown how many false positives the defective devices actually demonstrated.\u00a0As reported by CNN, \u201cIn February, the Biden administration announced a\u00a0$231.8 million award\u00a0for Ellume USA for production of its at-home tests for the US. But demand for home tests has remained high and supply limited. This fall, the Biden administration announced billions more dollars to help make\u00a0more tests available.\u201dThe Daily Wire is one of America\u2019s fastest-growing conservative media companies and counter-cultural outlets for news, opinion, and entertainment. Get inside access to The Daily Wire by becoming a member.<\/p>\n","protected":false},"author":95,"featured_media":2315279,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"","fifu_image_alt":"","footnotes":""},"categories":[],"tags":[],"class_list":["post-998969","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/998969","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/95"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=998969"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/998969\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/2315279"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=998969"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=998969"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=998969"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}