(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).A field service engineer was dispatched on (b)(4) 2016.The fse replaced the rotor seal, stator face assembly, and the uptake and purge check valves.The fse ran qc (quality control) and several patient samples with resulting areas in the acceptable range.The instrument was verified as operational.There was no further action by field service required.The most probable cause of the reported event was the purge check valve.
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