A user facility called magellan's product support on to report used sensor error messages on their leadcare ii blood lead analyzer.Testing of the returned unit at magellan replicated error messages, and produce qc results that were out of range.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).
|