The customer complained of a questionable result for 1 patient sample tested for elecsys cmv igm immunoassay (cmv igm) on a cobas 8000 e 602 module compared to an architect analyzer.The initial cmv igm result was 0.207 coi, non-reactive.The sample was tested in another laboratory on an architect analyzer that obtained a cmv igm result of 13.87 index, reactive.The erroneous result was not released outside of the laboratory.There was no allegation of an adverse event.The cobas e602 serial number was (b)(4).The investigation is currently ongoing.
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