The instrument history log shows that from 01apr2019 through 17jun2019 there are 208 occurrences of error code 0550 cuvette washing not completed error, hardware failure or user pressed stop, and 543 occurrences of error code 3375 unable to process test, aspiration error occurred.The maintenance log shows periodic maintenance was performed as required; however, the as-needed maintenance procedure 6052 wash cuvettes was not performed following any of the occurrences of error code 0550 as instructed in the architect operations manual.The quality control log review of oct 2018 through june 2019 shows quality control in range.The trend review by the product list number found no adverse trends related to this issue.A device history review showed no issues that were associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.No customer return was available for evaluation.No product deficiency was identified.
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