Investigation conclusion: the customer's complaint was not replicated during in-house testing of retained devices of lot number t14219n.Retains of the complaint lot were tested with a positive calibrator, no issues with d-dimer recovery were observed.Lot performed within specification.Manufacturing batch records for lot t14219n were reviewed and found that the lot met final release specifications.Based on the information available, there is no indication of a product deficiency and no correction action is required.
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