(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2016, a field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse removed a piece of the barcode label that was stuck to the backside of the sampling station.This caused the tube sensor to intermittently be active when no rack was in position, causing the x1 axis error.All errors cleared and the g8 instrument is operational.No further action is required by field service.The most probable cause of the reported event was due to operator error.
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On (b)(6) 2016, a customer reported error 708 x-1 axis with the g8 analyzer.The customer is unable to run hba1c patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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