ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I CA 19-9XR ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 74611FP00. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS FOR THE COMPLAINT LOT 74611FP00. THE OVERALL PERFORMANCE OF THE ALINITY I CA 19-9XR REAGENT LOT 74611FP00 IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIANS ARE WITHIN THE ESTABLISHED LIMITS; THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR LOT 74611FP00. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT 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 74611FP00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR MULTIPLE PATIENTS. NO MEDICAL HISTORY FOR THE PATIENTS WERE PROVIDED BY THE CUSTOMER BECAUSE THEY ARE A COMMERCIAL LABORATORY WITH NO ACCESS TO PATIENT INFORMATION, THEREFORE IT IS NOT KNOWN IF THE PATIENTS¿ HAVE A HISTORY OF CANCER. THE FOLLOWING DATA WAS PROVIDED: PATIENT #1: SAMPLE ID (B)(6) (60-YEARS OLD). PREVIOUS MEASURED CA 19-9 RESULT ON 21MAY2024 WAS 24.5 U/ML. ON 26AUG2025 RESULT GENERATED ON (B)(6) = 37.41 U/ML; SECOND RUN RESULT = 37.65; THIRD RUN RESULT = 26.66 U/ML. RESULT GENERATED ON ANOTHER INSTRUMENT (B)(6): FIRST RUN = 25.07 U/ML; SECOND RUN = 26.56 U/ML; THIRD RUN = 25.01 U/ML. THE CUSTOMER REPORTED THE CA 19-9 RESULT OF 26.6 U/ML FROM THE SAMPLE TESTED ON 26AUG2025 TO THE CLINICIANS WITH NO INQUIRY FROM THE CLINICAL TEAM. PATIENT #2, SAMPLE ID (B)(6): ON (B)(6) 2025: UNIT 2 (B)(6) RESULTS = 44.4 / 141.57 /5.30 U/ML. UNIT 1 (B)(6) RESULTS = 4.6 / 3.94 U/ML. CONTROLS WERE WITHIN RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. A1 - PATIENT IDENTIFIER: (B)(6) (60-YEARS OLD) / (B)(6) (2 DIFFERENT PATIENTS IN TOTAL) 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 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21, WITH 510K/PMA/BLA NUMBER K052000.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR MULTIPLE PATIENTS. NO MEDICAL HISTORY FOR THE PATIENTS WERE PROVIDED BY THE CUSTOMER BECAUSE THEY ARE A COMMERCIAL LABORATORY WITH NO ACCESS TO PATIENT INFORMATION, THEREFORE IT IS NOT KNOWN IF THE PATIENTS¿ HAVE A HISTORY OF CANCER. THE FOLLOWING DATA WAS PROVIDED: PATIENT #1: SAMPLE ID (B)(6) (60-YEARS OLD), PREVIOUS MEASURED CA 19-9 RESULT ON (B)(6) 2024 WAS 24.5 U/ML, ON (B)(6) 2025 RESULT GENERATED ON (B)(6) = 37.41 U/ML; SECOND RUN RESULT = 37.65; THIRD RUN RESULT = 26.66 U/ML, RESULT GENERATED ON ANOTHER INSTRUMENT (B)(6): FIRST RUN = 25.07 U/ML; SECOND RUN = 26.56 U/ML; THIRD RUN = 25.01 U/ML. THE CUSTOMER REPORTED THE CA 19-9 RESULT OF 26.6 U/ML FROM THE SAMPLE TESTED ON (B)(6) 2025 TO THE CLINICIANS WITH NO INQUIRY FROM THE CLINICAL TEAM. PATIENT #2, SAMPLE ID (B)(6): ON (B)(6) 2025: UNIT 2 (B)(6) RESULTS = 44.4 / 141.57 /5.30 U/ML, UNIT 1 (B)(6) RESULTS = 4.6 / 3.94 U/ML. CONTROLS WERE WITHIN RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.