(b)(4).This issue was previously reported under mdr number 3002809144-2017-00118 under the same suspect medical device but an incorrect manufacturer name, city and state.No customer returns were available.Investigation of the customer issue included a review of the complaint text, a search for similar complaints and a review of labeling.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for architect ca 19-9xr reagent lot 67005m800.Historical performance of the reagent lot was evaluated using world wide data from abbott link.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for this lot is within the established control limits which indicates that the lot is performing acceptably and comparable to other lots in the field.Labeling was reviewed and found to be adequate.Off label use was identified as the patient was not being monitored for pancreatic cancer.Based on the available information, no product deficiency of architect ca 19-9xr reagent lot 67005m800 was identified.
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