This report is being submitted due to a retrospective review conducted under capa(b)(4).(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).Device evaluation by manufacturer: the field service engineer (fse) was dispatched on (b)(6) 2016.The fse replaced allthe peek tubing and rebuilt the injection valve.The fse upgraded the software to version 5.23 and performed preventive maintenance, on seperaste ticket.Quality control and patient samples were run without error.The g8 was working as intended.No further action required by fse.The probable cause of the event was a clog in the line.
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