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. ALL AVAILABLE PATIENT INFORMATION WAS PROVIDED, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. 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

THE CUSTOMER OBSERVED IMPRECISE RESULTS FOR THE ALINITY CA 19-9XR FOR 3 PATIENTS. CLINICAL HISTORY IS UNKNOWN FOR THE PATIENTS. THE FOLLOWING DATA WAS PROVIDED: 73-YEAR-OLD MALE MULTIPLE SAMPLES. CUSTOMER IS QUESTIONING THE RESULT FROM (B)(6) 2026: SID (B)(6), PROCESSED ON (B)(6) 2026 = 1034.27 U/ML. SID (B)(6), PROCESSED ON (B)(6) 2026 = 270.59 U/ML. SID (B)(6), PROCESSED ON (B)(6) 2026 = 236.94 U/ML. HISTORICAL RESULTS: SID (B)(6), PROCESSED ON (B)(6) 2026 = 169.39 U/ML. SID (B)(6), PROCESSED ON (B)(6) 2026 = 180.56 U/ML. SID (B)(6), PROCESSED ON (B)(6) 2026 = 160.12 U/ML. 25-YEAR-OLD FEMALE SID (B)(6), INITIAL RESULT = 40.82 REPEAT RESULT = 74.56 U/ML, 63-YEAR-OLD FEMALE SID (B)(6), INITIAL RESULT = 57.31 REPEAT RESULT = 85.83 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.