Your effort and contribution in providing this feedback is much People could unnecessarily isolate themselves and miss out on social, school, and work commitments. Visit www.ellumecovidtest.com/return for more instructions or call 1-888-807-1501 or email productsupport@ellume.com. The spokesperson added that the FDA did not indicate that the tests themselves caused harm, but rather the impact of the manufacturing error. Remove affected products from their shelves and cease sales and distibution. The company issued a voluntary recall of their at-home test on January 31, following reports that the test kits were illegally imported into the US, the FDA said. This recall has been identified by the FDA as a Class I recall, the most serious type of recall, as use of these tests may cause serious adverse health consequences or death. The FDA said false positives could lead to a delayed diagnosis or treatment of the actual cause of a persons illness; receiving unnecessary Covid-19 treatment which may have side effects; and disregard for precautions against Covid-19, including vaccination. Bondi Partners. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. "But it's also critical for others you interact with, because you can potentially infect them. Ken Alltucker is on Twitter as@kalltuckeror can be emailed at alltuck@usatoday.com. But demand for home tests has remained high and supply limited. If you are a clinical or public health laboratory professional. FDA Recalls Over 2 Million Ellume At-Home Covid Test Kits Due to Cue COVID-19 Test for Home and Over The Counter Use. If you do decide to purchase an at-home test online, it's important to look at online reviews to make sure the seller is trustworthy. New cases and investigations, settlement deadlines, and news straight to your inbox. Federal Trade Commission. However, an itchy throat is more commonly associated with allergies. The Laboratory Outreach Communication System, Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS), Center for Surveillance, Epidemiology, and Laboratory Services (CSELS), Centers for Disease Control and Prevention (CDC). So far there have been 35 recorded false-positive tests sent to the FDA and no recorded deaths. About 195,000are unused and can be replaced with new tests as part of the recall. We believe at-home diagnostic tests play a critical role in the fight against COVID-19. So, there are any number of circumstances where these tests might be used.. But It's Tricky to Get One. Ellume identified a total of 427,000 tests from the recalled lots.

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