No returns were made available from the customer site for this evaluation.Accuracy testing was performed using a retained kit of architect afp assay lot 46114lf00 across three architect isystems by running 16 replicates each of an afp low panel sample on each analyzer.All results met specifications indicating acceptable product performance.A review of data from the customer site along with instrument logs downloaded from the analyzer found no unusual performance issues.A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.The architect afp assay package insert and the architect operation manual both contain information to address the current customer issue.Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred.The issue was addressed through standard troubleshooting procedures.Catalog#, corrected from 03p36-20 to 03p36-30.
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