WebOct 1, 2024 · The communications informed customer that the Recalling Firm has received a number of complaints stating false positive test results for it COVID-19 Home Test kits. If … WebOct 5, 2024 · While neither the FDA nor Ellume gave the exact amount of kits that are being recalled, the New York Times said the number was “nearly 200,000.” A total of 427,000 kits sent to the US have been affected by the unspecified issue, and half have already been used, resulting in about 42,000 positive results, the paper said.
Cardinal Health Issues Nationwide Recall of Select Monoject™ …
WebOct 20, 2024 · Now, Australian company Ellume is recalling nearly 200,000 test kits. The company learned that the devices returned too many false-positive results because of a manufacturing error. Details About the Recall In the past few weeks, the company noticed that some of its kits were returning a higher-than-expected rate of false positives. WebOct 6, 2024 · An Australian medical technology manufacturer recalled some of their COVID-19 at-home test kits supplied in the United States after reports of some false-positive results surfaced. The Brisbane-based company, Ellume, manufactured the kit and signed a $300 million deal with the United States earlier this year to deliver the fast at-home antigen test … makerere university business school login
COVID-19 home tests recalled over false-positive results
WebMar 31, 2024 · Diagnostic tests can show if you have an active COVID-19 infection. These at-home OTC COVID-19 diagnostic tests are FDA authorized for self-testing at home (or in other locations). This means you collect your own sample, perform the test, and read the result yourself without the need to send a sample to a laboratory. WebNov 11, 2024 · The lot number is found on a sticker on the side of the product carton. Judge overturns Texas mask mandate ban for schools. ... The FDA said the Ellume case is a Class I recall, which it said is ... WebNov 11, 2024 · The U.S. Food and Drug Administration has announced a recall of about 2 million at-home COVID-19 test kits made by the Australian-based biotech company Ellume. The federal regulatory agency... makerere university business school mba