The field service representative observed much dried material around the waste diverter area; as well as dried buffer salts in the optics area.The issue was considered resolved after both waste diverter and optics areas were cleaned and the sample, r1 and r2 probes were calibrated on the architect i2000sr.The field service representative verified the system function with an optics check and a control/mini precision run (all results were in the 0.5% range).The service history of the serial (b)(4) verifies no subsequent issues have been reported since the parts were clean/calibrated.No contributing factors in the month prior to the complaint were identified in regards to the architect i2000sr system.A product labeling review found the architect systems operations manual addresses requirements for handling specimens, operational precautions and limitations and troubleshooting for the reported issue.Numerous probable causes are listed for the sample results observed problems erratic assay results and elevated concentration.The causes include: probe is not positioned correctly; sample was not collected and/or prepared correctly; and hardware failure.The architect havab-g package insert adequately address sample handling, performance characteristics, assay processing, and interpretation of results.A review of the architect product monitoring found no similar issues as described in this complaint; nor was a trend identified with the architect i2000sr erratic result rate.Taken together, there is no indication of a deficiency of the architect i2000sr analyzer.
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