The investigation has determined that unexpected vitros tsh results were obtained from non-vitros quality control samples.The investigation was unable to determine an assignable cause.A review of historical tsh quality control data indicates that the qc shifted low on the vitros 5600 system one day after a recalibration event.The same tsh reagent lot and qc fluids were processed on an alternate vitros eci system and tsh qc results shifted high (in opposite direction) one day after the calibration event.This would suggest a potential issue with qc fluid handling and storage.The pre-analytical qc fluid preparation, storage and handling processes was not obtained.It is unknown if the laboratory began using a new vial or box of qc fluid on the day of the qc shift.It is possible that improper qc fluid handling was a potential contributor to the low qc results.There was no indication of a vitros 5600 or eci instrument malfunction.However, no precision testing was processed to confirm instrument performance.Therefore, an instrument issue cannot be entirely ruled out.
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The customer obtained unexpected tsh results from non-vitros quality control samples using vitros immunodiagnostic products tsh reagent on a vitros 5600 integrated system and a vitros eci immunodiagnostic system.Vitros 5600 system: biorad level 1 (lot 40320) = 0.112, 0.120, 0.125 versus expected 0.211 miu/l.Biorad level 2 (lot 40320) = 3.47, 3.56 versus expected 5.236 miu/l.Vitros eci system biorad level 2 (lot 40320) = 7.78, 7.83, 7.93 versus expected 5.236 miu/l.Biased results of the direction and magnitude observed could lead to inappropriate physician action.No erroneous patient sample results were reported from the laboratory, and there was no allegation of patient harm.This report is number one of four 3500a forms filed for this event, as four devices were affected.This report corresponds to ortho clinical diagnostics inc.(b)(4).
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