ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

A REVIEW OF COMPLAINTS FOR ALINITY I CA 19-9XR (LOT 78765FP00) ASSAY DETERMINED THAT THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. HISTORICAL PERFORMANCE IN THE FIELD OF REAGENT LOTS USING WORLD-WIDE DATA WAS EVALUATED. THE PATIENT MEDIAN RESULT FOR LOT 78765FP00 WAS ANALYZED AND FOUND TO BE WITHIN ESTABLISHED BASELINES AND CONFIRMS NO SYSTEMIC ISSUES FOR THIS LOT. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I CA 19-9XR (LOT 78765FP00) ASSAY.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA 19-9XR RESULT ON A PATIENT. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. RESULTS PROVIDED: ON (B)(6) 2025, SID (B)(6) = >1200 / 1078, X10 DILUTION = 26.2 / 36 U/ML, PREVIOUS RESULT FROM (B)(6) 2025 = 70.5 U/ML , NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

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. SECTION A1 PATIENT IDENTIFIER COMPLETE SID: (B)(6). 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, WITH 510K/PMA/BLA NUMBER K052000.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA 19-9XR RESULT ON A PATIENT. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. RESULTS PROVIDED: (B)(6) 2025 SID (B)(6) = >1200 / 1078, X10 DILUTION = 26.2 / 36 U/ML. PREVIOUS RESULT FROM (B)(6) 2025 = 70.5 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.