All Rights Reserved. Three over-the-counter COVID-19 tests are now available at CVS, Walgreens, and Walmart pharmacies. "But it's also critical for others you interact with, because you can potentially infect them. More than 2 million tests made by the company that were distributed between April 13, 2021, and Aug. 26, 2021, are now targeted. The FDA says that there have been 35 reports of false positives, and no reported deaths. But demand for home tests has remained high and supply limited. Ellume expands recall of rapid at Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. CNN More than 2 million of Ellumes at-home Covid-19 tests have been recalled by the company due to higher-than-acceptable false positives. Immediately notify the Recalling Firm of any accounts or additional locations that may have received the affected product. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. COVID-19 test kit maker Ellume is recalling some at-home tests after learning that they were reporting a higher-than-expected rate of false positive results indicating After taking an at-home COVID testwhich the FDA considers a "critical" part in the fight against COVID"individuals with positive results should self-isolate and seek additional care from their health care provider. Grace holds a dual degree in journalism and science in human cultures from Northwestern University with a concentration in environment, science, and society. All rights reserved. COVID While Health is trying to keep our stories as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDC, WHO, and their local public health department as resources. Affected tests that are not yet used will be disabled via a software update. 1. more than 2.2 million at-home rapid antigen COVID-19 test kits. Saving Lives, Protecting People, CDCs Laboratory Outreach Communication System (LOCS), Information for Laboratories about Coronavirus (COVID-19), Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories, CDC Laboratory Outreach Communication System (LOCS), Clinical Laboratory COVID-19 Response Calls, CDC's Laboratory Outreach Communication System (LOCS), U.S. Department of Health & Human Services. "The Ellume team offers its sincere apologies for the stress or difficulties people may have experienced due to a false-positive result.". The company is already producing and shipping new, unaffected test kits to the U.S., the spokesperson said. "You have my personal commitment that we have learned from this experience, we have implemented additional controls, we are continuing to work on resolving the issue that led to this recall and we are going to do everything in our power to regain your trust," Parsons said. Here's what to know about all of the at-home COVID-19 tests that have been recalledand which ones are deemed safe and effective by the FDA. The Centers for Disease Control and Prevention offers detailed guidance about at-home tests, saying they are a good option if you need to be tested for COVID-19 and can't get tested by a health care provider. The lawsuit alleges Ellume has refused to provide to test buyers the relief it implicitly agreed to provide when it voluntarily recalled the at-home COVID-19 tests. The Ellume team offers its sincere apologies for the stress or difficulties people may have experienced due to a false-positive result. Claire Wolters is a staff reporter covering health news for Verywell. You can have troubles on both sides, he added. Ellume recalled around 195,000 of its at-home COVID-19 tests in October because of a manufacturing error that resulted in too many false-positive results. U.S. Food and Drug Administration.
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