ARCHITECT CA19-9XR

Description of Event or Problem

THE CUSTOMER OBSERVED ERRATIC ARCHITECT CA 19-9XR FOR A (B)(6) FEMALE WITH JAUNDICE. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2026, SID (B)(6): INITIAL CA 19-9 RESULT= 1156.97 U/ML; REPEAT RESULTS = >1200.00 U/ML, >1200.00 U/ML; REPEAT RESULTS (1:10 DILUTION) = 194.61 U/ML, 180.22 U/ML, 16.92 U/ML; REPEAT RESULT (1:3 DILUTION) = 179.72 U/ML; REPEAT RESULT (1:5 DILUTION) = 64.13 U/ML; REPEAT RESULT (1:30 DILUTION) = 3.19 U/ML. TESTING WAS REPEATED ON (B)(6) 2026: INITIAL CA 19-9 RESULT = >1200.00 U/ML; REPEAT RESULT (AUTO 1:10 DILUTION) = 170.29 U/ML; REPEAT RESULT (1:3 DILUTION) = 133.34 U/ML; REPEAT RESULT (1:5 DILUTION) = 53.83 U/ML; REPEAT RESULTS (1:10 DILUTION) = 17.41 U/ML, 61.65 U/ML; 99.79 U/ML, 158.31 U/ML. THE RESULTS OF REPRODUCIBILITY TESTING WERE AROUND THE SAME AS THE INITIAL RESULTS AND THE RESULT AFTER TREATMENT WITH NEURAMINIDASE WAS DECREASED. 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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02K91-39 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91-33, WITH 510K/PMA/BLA NUMBER K052000.