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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P32-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21 WITH 510K/PMA/BLA NUMBER K052000. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS FOR ONE SAMPLE FROM A TESTING CENTER. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2026 SID (B)(6) INITIAL RESULT = >1,200.00 U/ML, REPEAT RESULT WITH 1:10 DILUTION = 24.58/ U/ML, 1:10 AUTOMATIC DILUTION RESULTS = 224.61 U/ML, 241.52 U/ML, UNDILUTED RESULT = >1,200.00 U/ML, 1:2 DILUTION = 715.82 U/ML, 1:4 DILUTION = 367.26 U/ML, 1:8 DILUTION = <240.00 U/ML. RESULTS ON ALTERNATIVE ALINITY I (SN (B)(6)): (B)(6) 2026 INITIAL RESULT = > 1,200.00 U/ML, REPEAT RESULT WITH AUTO DILUTION 1:10 = 226.25 U/ML, REPEAT RESULT = >1200.00 U/ML, REPEAT WITH 1:2 DILUTION = 691.05 U/ML, 1:4 DILUTION = 435.04 U/ML, 1:8 DILUTION <240.00 U/ML, AUTOMATIC 1:10 DILUTION = 204.68 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.