ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P32-20, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21, AND A 510K NUMBER OF K052000.

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 68-YEAR-OLD MALE PATIENT DIAGNOSED WITH PANCREATIC CANCER. THE PATIENT IS BEING TESTED FOLLOWING TREATMENT. THE FOLLOWING DATA WERE PROVIDED: SID (B)(6): LOT# 79769FP00 RAN ON (B)(6): (B)(6) 2026 RESULTS = > 1,200.00 U/ML, DILUTED RESULT = 726.36 U/ML. (B)(6) 2026 RESULTS = > 1,200.00 U/ML, DILUTED RESULT = 800.72 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

TRACKING AND TRENDING DATA REVIEW FOR THE ALINITY I CA 19-9XR ASSAY AND LOT 79769FP00 FOUND NO TRENDS RELATED TO THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ALINITY I CA 19-9XR ASSAY IN THE FIELD WAS REVIEWED USING DATA FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN RESULT FOR LOT 79769FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR THE LOT. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I CA 19-9XR REAGENT LOT 79769FP00 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 68-YEAR-OLD MALE PATIENT DIAGNOSED WITH PANCREATIC CANCER. THE PATIENT IS BEING TESTED FOLLOWING TREATMENT. THE FOLLOWING DATA WERE PROVIDED: SID (B)(6): LOT# 79769FP00 RAN ON (B)(6): (B)(6) 2026 RESULTS = > 1,200.00 U/ML, DILUTED RESULT = 726.36 U/ML (B)(6) 2026 RESULTS = > 1,200.00 U/ML, DILUTED RESULT = 800.72 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.