(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).On (b)(6) 2016, an fse conducted on-site follow-up with the customer.The fse observed a small leak in the tubing from the pump to the r-4 valve.The tubing was replaced but the retention times were unstable.The fse replaced the 2-way buffer solenoid valves which returned the instrument to normal operation.The most probable cause of the reported event was due to defective 2-way-solenoid valves.
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On (b)(6) 2016, a customer reported p00 peaks on their g8 analyzer.The customer is unable to report 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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