ellume covid test recall refund

More than 2 million tests Sign up for notifications from Insider! You can find out more about our use, change your default settings, and withdraw your consent at any time with effect for the future by visiting Cookies Settings, which can also be found in the footer of the site. According to the FDA, customers with an Ellume Covid-19 Home Test can determine whether or not it has been a part of the recall by locating the product lot number on the side of the product and comparing it to the recalled lot numbers listed in the Medical Device Recall Database Entry. According to the complaint, a false positive COVID-19 test result can lead someone to receive unnecessary treatment from healthcare providers, which may cause side effects. USA TODAY last month reportedthat several consumerswho purchasedEllume tests complainedabout false positive results when compared with laboratory-based PCR tests. Its too soon, so youll have to wait several days before you do it in order to get a more reliable result, he said. "If anyone is concerned that their test may be affected by a recall, these would be the two places to check," FDA press officer James McKinney tells Health. We share this concern, which is why we worked quickly to remove affected tests from store shelves and online platforms and notified impacted customers and retailers.. More research is needed to, While many of the previous strains of COVID-19 have all presented with classic symptoms of cough, congestion, body aches, and even loss of taste. The tests can give people false-positive results for the coronavirus. On November 10, 2021, the US Food and Drug Administration (FDA) announced a class I recall, Potential for false positive results with certain lots of Ellume coronavirus disease-19 (COVID-19) home tests due to a manufacturing issue.1 False-positive results indicate coronavirus 2019 (COVID-19) infection when there is none. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. Ellume RAT According to the company website, the test is for people with or without symptoms and is usually able to provide results that are 96% accurate in 15 minutes. ACON Laboratories. See additional information. Thank you, {{form.email}}, for signing up. Itchy Throat: Could It Be COVID-19 or Something Else. Note: If you need help accessing information in different file formats, see

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