A field service engineer (fse) was at the customer site to address the reported issue.The issue was confirmed on the error log and replicated by powering on the analyzer.The fse resolved the issue by correcting the sorter alignment.Instrument validation was completed by performing quality control (qc).Qc results passed within the published ranges.The aia-2000 analyzer returned to operation.No further action required by field service.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4), from 14sep2018 to aware date (b)(6) 2019.No other similar complaints were identified during the search period.The aia-2000 operator's manual states the following: [4041] sorter y-axis home detection failure cause: the home sensor failed to activate after the sorter y-axis moved toward the home position.If retry fails, the measurement result will be flagged (mf flag).Solution: contact tosoh service center or local representatives.The probable cause of the issue is attributed to sorter alignment.
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A customer reported receiving error message 4041 sorter y-axis home detection failure while operating on the aia-2000 analyzer.The customer performed an all set home and noticed a loud grinding noise coming from the analyzer.A field service engineer (fse) was dispatched to address the reported issue, which resulted in delayed reporting of, beta-human chorionic gonadotropin (bhcg), and alpha-fetoprotein (afp) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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