(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).Fse was dispatched and on 11- and 12-aug-2016 replaced sample loop and verified proper operation.Replaced sample needle.Performed customer training on sample loop replacement.Verified proper operation and no leaks.Ran calibration and qc, passed.Customer states low total area when running patient samples, suspect faulty rehodyne valve.Replaced rehodyne valve and verified proper operation.Ran precision, calibration, and qc, all passed.The most probable cause of the reported event was an injector valve failure.
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On (b)(6) 2016, the customer reported leak at the injector valve with their hlc-723g8 analyzer.Customer reported a fluid leak at the injector valve.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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