It is indicated that the product is not returning for evaluation.Therefore, a review of the entire in-house testing history of the lot was performed.In-house strip testing on the reported strip lot meets release criteria.The product performed as expected.A review of the manufacturing batch records for the reported strip lot did not uncover any non-conformances.The lot meets release specifications.The customer did not provide a reference value for comparison.The accuracy of the customer's inratio inr result could not be determined without additional information.Although the root cause analysis did not include return testing, improper techniques were identified in the complaint.These could not be ruled out as a cause of the unexpected results.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.
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