Caller questioning why results are flagged high on the aclh 500 but not on the triage meter.On (b)(6) 2021: aclh 500 874 feu vs.Triage meter, 504 ddu.Caller stated both testing methods were accidentally requested.On (b)(6) 2021: aclh 500, 878 feu vs.Triage meter, 561 ddu.Site cutoffs: 500 feu for aclh 500; 600 ng/ml for triage meter.Caller stated there were no issues with triage controls or cal vers, results within 1sd.No further information available as customer is not responding.Unsure what treatment if any was provided or withheld.
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Investigation conclusion: the customer's complaint was not replicated during in-house testing of retain device lot t11855n.Retains of the complaint lot were tested with a positive calibrator, no issues with d-dimer recovery were observed.The lot performed properly.Manufacturing batch records for lot t11855rn 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 corrective action is required.
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