A user facility called magellan's product support on to report test failed error messages on their leadcare blood lead analyzer.The analyzer was returned to magellan for evaluation.During investigative testing, magellan observed repeated failed external control tests.Error messages were confirmed when reviewing the analyzer log files.No reported harm or injuries occurred as a result of this issue.Corrosion was noted on sensor pins.Corrosion of the sensor pins occurs when there is overexposure of the analyzer pins to the assay's acidic treatment reagent.This occurs when used test sensors are not removed immediately after testing (per instrument instructions) or when too much sample is added to the test sensor.Periodic testing with blood lead qc controls is used to monitor analyzer performance.Magellan provided the customer with a new instrument, additional training, sent them notifications.No further issues of this nature have been shown for this customer.Note: late filing is part of magellan diagnostics, inc.Response to fda's 483 issued on (b)(4) 2017.(b)(4).Customer complaint: (b)(4).
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