ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I CA 19-9XR REAGENT LOT 77708FP00. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. HISTORICAL PERFORMANCE OF REAGENT LOT 77708FP00 EVALUATED USING WORLDWIDE FIELD DATA FOR THE ALINITY I CA 19-9XR ASSAY. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THE PATIENT MEDIANS WERE WITHIN THE ESTABLISHED LIMITS, INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY IN THE FIELD. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I CA 19-9XR REAGENT LOT 77708FP00.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA19-9XR RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025, SID (B)(6): INITIAL RESULT = 100.70 U/ML, REPEATS = 11.4 U/ML AND 12.1 U/ML IT IS UNKNOWN IF THE PATIENT WAS DIAGNOSED WITH PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

COMPLETED INFORMATION FOR SECTION A1 PATIENT IDENTIFIER: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P32-30 HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA19-9XR RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025, SID (B)(6): INITIAL RESULT = 100.70 U/ML, REPEATS = 11.4 U/ML AND 12.1 U/ML. IT IS UNKNOWN IF THE PATIENT WAS DIAGNOSED WITH PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.