The customer observed falsely high platelet counts (plt) for multiple patients generated using the cell-dyn emerald analyzer.The following data was provided.The customer uses normal range 140 to 440.(b)(6) initial 1324, repeat 586.(b)(6) initial 1353, repeat 414, 399.(b)(6) initial 329, repeat 1045, 939, 321.No impact to patient management was reported.
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Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling, and a review of instrument service.No returns were made available from the customer site for this evaluation.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.Cell-dyn emerald analyzer serial number (b)(4) service history was reviewed and no contributing factors were found.Based on all available information and abbott diagnostics complaint investigation, no product deficiency was identified.
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