There was an allegation of questionable elecsys toxo igg immunoassay results for 1 patient sample on a cobas e 801 analytical unit compared to an abbott alinity analyzer and a biomérieux vidas analyzer.On (b)(6) 2022, the initial toxo igg result was 50.70 iu/ml, interpreted as reactive.On (b)(6) 2022, the sample was repeated and the result was 56.90 iu/ml, interpreted as reactive.The sample was tested on an abbott alinity analyzer and the result was 1.4 iu/ml, interpreted as non-reactive.The sample was also tested on a biomérieux vidas analyzer and the result was 2 iu/ml, interpreted as non-reactive.No questionable results were reported outside of the laboratory.The e801 serial number is (b)(4).
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