Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w64982n.No issues with d-dimer recovery were observed, lot performed properly.Manufacturing batch records for the lot were reviewed, lot met release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.Although this catalog number (97300eua) is not approved in the united states, this event is being reported as the device is same/similar to catalog number 98100, 510(k) number k042890.
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