Investigation conclusion: the customer's complaint was not replicated during in-house testing of retained devices of lot number t14089rbn.Devices of the complaint lot performed properly when testing with a positive calibrator, no issues with d-dimer recovery were observed.Lot performed within specification.Manufacturing batch records for lot t14089rbn 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.The customer mentioned that a patient was male and born in 1973, however, this case is related to another case with a different patient and device lot and the customer did not confirm which case the patient information was related to.
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