ALINITY I CA 19-9XR REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I CA19-9XR RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING EXAMPLE DATA WAS PROVIDED: INITIAL RESULT = 40, REPEAT = 10 INITIAL RESULT = 50, REPEAT = 11 IT IS UNKNOWN IF THE PATIENTS WERE DIAGNOSED WITH PANCREATIC CANCER. 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. 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.

Description of Event or Problem

ADDITIONAL DATA WAS PROVIDED FOR TWO ADDITIONAL SAMPLES THAT WERE IDENTIFIED DURING A REVIEW OF DATA ON INSTRUMENTS (B)(6) AND (B)(6): INITIAL RESULT = 31, REPEAT = 5. INITIAL RESULT = 27, REPEAT = 3. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

SECTION B5 WAS UPDATED WITH ADDITIONAL DATA THAT WAS PROVIDED BY THE CUSTOMER ON 20OCT2025. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS STILL IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Additional Manufacturer Narrative

A TICKET SEARCH FOR COMPLAINT LOT 74583FP00 DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE ISSUE UNDER REVIEW. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I CA19-9XR ASSAY DID NOT IDENTIFY ANY TRENDS FOR COMPLAINT ISSUE. THE HISTORICAL PERFORMANCE OF REAGENT LOT NUMBER 74583FP00 WAS EVALUATED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR THE LOT NUMBERS IN THE FIELD FOR LOT NUMBER 74583FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS. A DEVICE HISTORY REVIEW FOR THE COMPLAINT LOT DID NOT IDENTIFY ANY NON-CONFORMANCES, DEVIATIONS, OR POTENTIAL NON-CONFORMANCES. 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 CA19-9XR ASSAY, LOT 74583FP00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I CA19-9XR RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING EXAMPLE DATA WAS PROVIDED: INITIAL RESULT = 40, REPEAT = 10, INITIAL RESULT = 50, REPEAT = 11, IT IS UNKNOWN IF THE PATIENTS WERE DIAGNOSED WITH PANCREATIC CANCER. ADDITIONAL DATA WAS PROVIDED FOR TWO ADDITIONAL SAMPLES THAT WERE IDENTIFIED DURING A REVIEW OF DATA ON INSTRUMENTS (B)(6): INITIAL RESULT = 31, REPEAT = 5, INITIAL RESULT = 27, REPEAT = 3. IT IS UNKNOWN IF THE PATIENTS WERE DIAGNOSED WITH PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.