Investigation conclusion: 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 testing on strip lot 373678a was found to be performing within expectations.A review of the manufacturing records for the lot did not uncover any non-conformances.The lot meets release specification.Although improper technique was identified and the customer had a condition that may impact the performance of the assay, the customer did not provide a laboratory reference value for comparison.Unable to determine the accuracy of the inratio result without this information.Root cause cannot be determined from the information provided.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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