The customer observed a falsely elevated architect i2000sr analyzer.The following data was provided: initial 1669.30ng/ml, repeated after a new draw 3.88, 3.66, 4.23ng/ml.There was no impact to patient management reported.
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Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and accuracy testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The product was not available for return.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
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