(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 replaced the stator face, rotor seal, injection valve seal, inlet and outlet check valves and sample loop.The fse verified proper operation and ran several patient samples to verify good chromatography.All results were within acceptable range.All errors cleared and the g8 instrument is operational.No further action is required by field service.The most probable cause for low total area was the sample loop failure.
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On (b)(6) 2016, a customer reported low total area on the g8 instrument.The customer is unable to run patient samples on hba1c diabetes assay.On (b)(6) 2016, a field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
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