A customer obtained 45 higher than expected vitros amon results from ortho and non-ortho biorad quality control fluids using vitros amon slide lot 1014-0239-3216 tested on a vitros 5600 integrated system.Vitros lpv i results of 90.7 umol/l compared to an expected result of 45.1 umol/l.Vitros lpv ii result of 256.3 umol/l compared to an expected result of 199.2 umol/l.Biorad liquicheck quality control fluid (lot#51962) results of 129.6, 126.5, 126.1, 123, 122.2, 121.4, 121.4, 121.2, 120.1, 119.7, 118.1, 117.7, 116.1, 115.7, 112.7, 111.2, 111, 108.9, 100.4, 99.1, 99, 98.8, 97.3, 97.1, 115.3, 131.4, 128.1, 127, 122.1, 121, 120, 119.5, 119.2, 118.7, 115.1, 114.9, 110.1, 106.6, 105.2, 103, 100.3, 99.3, 96.2 umol/l compared to an expected result of 80 umol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected.Ortho has not been made aware of any erroneous vitros amon results obtained or reported from the laboratory during the time frame of this event.However, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.There was no allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics (ortho) inc.Complaint numbers (b)(4).
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