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 checked for leaks and found the dilution well very dirty and caked with blood.A patient sample was run and the specimen was found to be not diluting.The engineer found the wash tubing not at the bottom and sticking above wash level sucking air, he pushed the wash tubing to the bottom of the wash and removed the air from wash syringe and tubing.Several patient samples were run.The fse also upgraded the software to 5.23.The g8 was working as intended.No further action required by fse.The probable cause of the event was the wash tubing sticking up out of wash sucking air.
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