The customer reported falsely elevated architect cyclosporine results.The following initial and repeat results were provided: sample id (b)(6): 171.2, 29.1 and 39.4 ng/dl , sample id (b)(6): 306.7, 77.2 and 79.3 ng/dl.No impact to patient management was provided.
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Investigation of the customer issue included a review of the complaint text, a search for similar complaints, in-house testing and a review of labeling.Tracking and trending report review for the architect cyclosporine assay determined that there were no related trends.An increase in complaint activity was not identified for reagent lot 01011m800.Internal cyclosporine panels were tested using a retained kit of reagent lot 01011m800.Acceptance criteria were met, which indicates acceptable product performance.Manufacturing documentation for the reagent lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect cyclosporine assay was identified.Section d11 concomitant medical products: the serial number was changed from isr52067 to isr52058 refer to related manufacturer report number 1628664-2019-00739 for the device evaluation of the architect i2000sr analyzer.
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