The investigation determined that higher than expected vitros ammonia (amon) results were obtained from a single vitros liquid performance verifier (lpv) i fluid and two different non-vitros biorad control fluids using three different vitros amon slide lots tested on a vitros 350 chemistry system.Vitros amon slide lot 1018-0254-2563: biorad lot 54350 level 3 amon result of 274.9 umol/l vs.The baseline mean of 220.0 umol/l.Vitros amon slide lot 1018-0256-9804: biorad lot 54350 level 1 amon result of 100.1 umol/l vs.The baseline mean of 19.0 umol/l.Vitros amon slide lot 1018-0256-4628: biorad lot 54350 level 1 amon result of 100.1 umol/l vs.The baseline mean of 19.0 umol/l.Vitros lpv i lot u8880 amon result of 106 umol/l vs.The midpoint of the rom value of 49.2 umol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.There was no report of affected patient results and there was no allegation of patient harm.This report is number one of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).
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