FDA expands recall of Ellume at-home COVID-19 tests to 2.2 People could unnecessarily isolate themselves and miss out on social, school, and work commitments. If you already used one of the affected kits and received a negative test result, know that that result still stands true. Cookies collect information about your preferences and your devices and are used to make the site work as you expect it to, to understand how you interact with the site, and to show advertisements that are targeted to your interests. Experts Explain How Patients Are Prioritized Amid COVID Surges. To receive email updates about this page, enter your email address: We take your privacy seriously. SCoV-2 Ag Detect Rapid Self-Test by InBios International, Inc. But again, if you buy your test from a reputable placeor order it directly from the governmentyou should be able to trust your purchase. COVID-19 At-Home Test by SD Biosensor, Inc. CLINITEST Rapid COVID-19 Antigen Self-Test. Rapid antigen tests can be useful to determine if you have an infection, but the timing and frequency could be key for accurate results. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Three over-the-counter COVID-19 tests are now available at CVS, Walgreens, and Walmart pharmacies. Here in the U.S., we need to do much more testing, more like whats available in Europe. ClassAction.org is a group of online professionals (designers, developers and writers) with years of experience in the legal industry. In November, the plaintiff received a check from Ellume for $215 but no explanation of how Ellume calculated the amount. The Food and Drug Administration (FDA) today classified the recall of Ellumes COVID-19 Home Test as Class I, the most serious type of recall. Ellume was the first company authorized by the FDA to sell COVID-19 testing kits in stores. Four rapid antigen testssometimes known as at-home COVID-19 testshave been recently recalled by the FDA. Customers can check their products lot number against the FDAs database. 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. At the start of the voluntary recall on October 1, Ellume reached out to its customers who tested positive before September 17 to notify them that their results could have been incorrect. At-home COVID-19 tests aren't nearly as hard to obtain as they were just a few months agobut with more test availability comes more chances of potentially picking up one that isn't authorized by the Food and Drug Administration. Theres no scientific evidence that drinking urine can protect you from COVID-19, and it may hurt you. The manufacturing issue did not appear to have affected negative results, according to the FDA. COVID Test Recall appreciated. Ellume RAT kits. The FDA issued a safety communication on October 6 alerting people of the potential of false-positive results from certain lots of the Ellume COVID-19 Home Test, due to manufacturing issues. Contact the Recalling Firm's sales representatives for further instructions on the disposal of affected product. If you are a clinical or public health laboratory professional. Ellume has investigated the issue, identified the root cause, implemented additional controls, and is working on resolving the issue that led to this recall. For Distributor and Retailers, they are instructed to: This product has been Certain batches of the Ellume tests have a higher than acceptable false-positive rate, but the FDA says negative test results arent affected. The number of recalled tests has grown to more than 2.2 million, up from the 427,000 tests that were included in the company's voluntary recall issued in October. The complaint argues that consumers did not know, and had no reason to know at the time of purchase that the Ellume COVID-19 tests could produce higher than acceptable false positives. If everyone had a negative test, that would reduce the risk of introducing the virus into that circumstance. The Ellume Difference: The Ellume COVID-19 Home Test was designed specifically for untrained, at-home use. Since the start of the pandemic, 268 COVID-19 tests have been removed from the market. 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. When you visit the site, Dotdash Meredith and its partners may store or retrieve information on your browser, mostly in the form of cookies.

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