Ellume covid-19 home test - i had false positive results on three tests and technical error on one further test.The ellume "analyser id" number for the three ellume false positive tests is (b)(4), and for the technical error test is (b)(4).These ellume tests were taken over the period from (b)(6) 2021 to (b)(6) 2021.Ellume states that none of these tests are from lot numbers included in ellume's current voluntary recall.In each case i had a second test performed by an independent laboratory within 24 hours of the incorrect ellume test result.In all cases the second test showed a negative result.The second tests were pcr tests and, in addition, i had two antigen tests performed shortly after the last ellume test (one a binaxnow antigen home test and one an antigen test performed by an independent laboratory) and both of these antigen tests also showed a negative result.I can provide you copies of all the tests performed by independent laboratories if you wish to see them.Based on the forgoing, it appears ellume's false positives problem extends beyond the lot numbers included in ellume's current voluntary recall.Fda safety report id # (b)(4).
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Additional information received from reporter for report mw5104574 on 12/7/2021.Please ref access number mw5104574.Ellume eventually included these tests in its broadened voluntary recall and sent me five replacements.Ellume covid-19 home tests with lot number pjoan-h.I used one of these yesterday, (b)(6) 2021, and received another false positive, confirmed by a negative pcr test done by an independent lab within 24 hrs.I have not used the other four replacement tests.I will send them to you if you request them within 48 hrs, otherwise i plan to throw them out.Fda safety report id# (b)(4).
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