The customer complained after observing imprecise vitros tsh results for their vitros free thyroid control material on a vitros eciq immunodiagnostic system.Control level 3 results of 25.6, 12.9 and 12.1 miu/l vs expected 18.4 miu/l.As part of troubleshooting, within-run vitros tsh precision tests were performed by the customer using the vitros free thyroid control material and further breaches of the potential health and safety criteria were observed: control level 1 results of 0.076, 0.076, 0.079, 0.077, and 0.078 miu/l vs expected 0.058 miu/l.Biased patient results of the direction and magnitude observed may lead to inappropriate physician action.The customer provided no information to suggest patient samples were similarly affected; however, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to occur undetected.There was no allegation of patient harm as a result of this event.This report is number two of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.(b)(4).
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