(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).Fse was dispatched and on 13-mar, 15-mar and 16-mar-2017 found bottom opto sensor on the right side of pipettor was positioned as low as it could go.Raised the bottom opto sensor.Cleaned pipettor guide shaft and lubricated it.Lubricated x rails.Cycled 3 patients in 3 separate racks in positions 1, 5, and 10 in the racks 3 times each no errors.Followed up.Error occured again.Installed new asm board.Instrument is operational.The most probable cause of the reported event was a faulty asm board.
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On (b)(6) 2017, the customer reported z axis error with their hlc-723g8 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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