On (b)(6) 2016 , an field service engineer conducted on-site follow-up with the customer where all connections were tightened, all of the reagents were changed and primed, and then the flow rate was adjusted.The instrument returned to normal operation.The most probable cause of the reported event was due to low flow rate.(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).This report is being submitted due to a retrospective review conducted under capa(b)(4).
|