ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

SECTION A3A - SEX: THIS SECTION WAS UPDATED FROM NO INFORMATION TO MALE. SECTION B5 - DESCRIBE EVENT OR PROBLEM: THIS SECTION WAS UPDATED WITH ADDITIONAL INFORMATION PROVIDED ON 03-NOV-2025. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P32-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08P32-21, WITH 510K/PMA/BLA NUMBER K052000. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): (B)(6) 2025 INITIAL ALINITY I CA 19-9XR RESULT = >1200 U/ML, DILUTED 1:10 RESULT = 482.89 U/ML. REPEAT UNDILUTED RESULT = 1159.11 U/ML. REPEAT DILUTED 1:10 RESULT = 447.30 U/ML. THE SAMPLE WAS RECENTRIFUGED AND RETESTED. UNDILUTED RESULT = 1198.38 U/ML. DILUTED 1:10 RESULT = 497.99 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. UPDATE: ON 03-NOV-2025, THE CUSTOMER PROVIDED ADDITIONAL INFORMATION. THE PATIENT IS MALE AND UNDERGOING CHEMOTHERAPY. THE CUSTOMER REPORTED THE RESULT OF 1159 U/ML WITH A COMMENT THAT IT WAS SUSPECTED.

Additional Manufacturer Narrative

A TICKET SEARCH FOR LOT 77707FP00 DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I CA 19-9XR ASSAY DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW FOR THE COMPLAINT LOT DID NOT IDENTIFY ANY ON-CONFORMANCES, DEVIATIONS, OR POTENTIAL NON-CONFORMANCES. THE OVERALL PERFORMANCE OF ALINITY I CA 19-9XR REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS REVIEW DID NOT IDENTIFY ANY UNUSUAL REAGENT LOT PERFORMANCE FOR THE LOT 77707FP00. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CA 19-9XR ASSAY, LOT 77707FP00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): (B)(6) 2025 INITIAL ALINITY I CA 19-9XR RESULT = >1200 U/ML, DILUTED 1:10 RESULT = 482.89 U/ML, REPEAT UNDILUTED RESULT = 1159.11 U/ML, REPEAT DILUTED 1:10 RESULT = 447.30 U/ML. THE SAMPLE WAS RECENTRIFUGED AND RETESTED. UNDILUTED RESULT = 1198.38 U/ML, DILUTED 1:10 RESULT = 497.99 U/ML, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. UPDATE: ON 03-NOV-2025, THE CUSTOMER PROVIDED ADDITIONAL INFORMATION. THE PATIENT IS MALE AND UNDERGOING CHEMOTHERAPY. THE CUSTOMER REPORTED THE RESULT OF 1159 U/ML WITH A COMMENT THAT IT WAS SUSPECTED.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P32-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08P32-21, WITH 510K/PMA/BLA NUMBER K052000. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED:: SID (B)(6). ON (B)(6) 2025 INITIAL ALINITY I CA 19-9XR RESULT = >1200 U/ML, DILUTED 1:10 RESULT = 482.89 U/ML REPEAT UNDILUTED RESULT = 1159.11 U/ML. REPEAT DILUTED 1:10 RESULT = 447.30 U/ML. THE SAMPLE WAS RECENTRIFUGED AND RETESTED. UNDILUTED RESULT = 1198.38 U/ML DILUTED 1:10 RESULT = 497.99 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED..