Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, review of instrument logs and a review of labeling.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
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The customer observed a falsely elevated calcium result on the architect c16000 analyzer.The following data was provided: sid (b)(6) initial 4.13, repeat 3.86, 2.41, 2.42 mmol/l.There was no impact to patient management reported.
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