Ellume lot numbers recalled
WebOct 6, 2024 · Ellume identified a total of 427,000 tests from the recalled lots. About 195,000 are unused and can be replaced with new tests as part of the recall. About 42,000 yielded positive results. WebThere is an increased chance that tests from the affected lot numbers may give a false positive result. The voluntary recall is being taken after specific product lots reported false-positive test result rates higher than was observed in clinical testing. The affected Ellume COVID-19 Home Tests were distributed to retailers and distributors from
Ellume lot numbers recalled
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WebOct 6, 2024 · Brisbane-based Ellume developed the test and earlier this year signed a $300 million deal with the US to supply the rapid at-home antigen tests. It received US Food and Drug Administration (FDA ... Web9. The recall did not end there: on or about November 10, 2024, Ellume identified additional defective lots of its Ellume COVID tests and issued a second voluntary recall of additional production lots, placing the total number of recalled Ellume COVID Tests at approximately 2,212,335 units. 10. The Food and Drug Administration (“FDA ...
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 … WebNov 11, 2024 · November 11, 2024. Here's a rapid-test recall to know about: The U.S. Food and Drug Administration (FDA) is recalling more than 2 million at-home COVID-19 tests …
WebOct 20, 2024 · Ellume recently recalled thousands of its at-home COVID-19 tests after some of them returned a higher-than-expected false positive results. ... “By year’s end, the manufacturer plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February 2024.” ... WebOct 5, 2024 · Questions about the recall can be directed to the Ellume Product Support Team at 1-888-807-1501, Monday through Friday, from 9 a.m. to 5 p.m. ET, to arrange a replacement test kit.
WebOct 5, 2024 · The FDA recommends checking to see if your Ellume COVID-19 Home Test is included in Ellume’s product recall by comparing the lot number on the test carton to …
WebOct 6, 2024 · Ellume identified a total of 427,000 tests from the recalled lots. About 195,000 are unused and can be replaced with new tests as part of the recall. About 42,000 … mary\u0027s trust in godWebNov 11, 2024 · November 11, 2024. Here's a rapid-test recall to know about: The U.S. Food and Drug Administration (FDA) is recalling more than 2 million at-home COVID-19 tests made by the Australia-based company ... hvac battery backupWebPlease fill out all mandatory fields to ensure your request can be fulfilled as quickly as possible. If you would like to speak to one of our Customer Support team members, … hvac bas trainingWebNov 13, 2024 · The U.S. Food and Drug Administration announced the recall of 2.2 million home COVID-19 tests made by Ellume, the first company to get FDA approval for over-the-counter COVID tests, due to “higher-than-acceptable false-positive test results.”. The recall is an expansion of last month’s recall of 200,000 kits for the same issue. hvac basis of designWebFeb 9, 2024 · Ellume recalled specific lots of the test following the warning, according to a recall alert published by the FDA on November 16. More than 2.2 million tests had been distributed between April 13 ... hvac bearing collar removalWebNov 15, 2024 · The Food and Drug Administration (FDA) has expanded its recall of Ellume at-home COVID-19 tests due to potential false-positive results. More than 2 million tests … hvac basic knowledge quizWebNov 10, 2024 · Recommendations for Test Users and Caregivers. Check if your Ellume COVID-19 Home Test is included in Ellume’s product recall by comparing the lot … hvac battle creek mi