ARCHITECT CA19-9XR
Received Mar 19, 2026 · Event occurred Mar 9, 2026
Report 3002809144-2026-00066 · MDR key 24639495
Device
Generic name
System, Test, Carbohydrate Ag (ca19-9), For Monit And Mgmt Of Pancreatic Cancer
Manufacturer
Abbott GmbhCatalog number
02K91-32
Lot number
81862FP00
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT CA 19-9XR RESULT GENERATED FOR A PATIENT SAMPLE. IT IS UNKNOWN IF THE PATIENT HAS A HISTORY OF PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 0-37 U/ML): SAMPLE ID (B)(6) INITIAL RESULT = 196.24 U/ML, REPEAT RESULTS = 24.91 U/ML, 25.54 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
REVIEW OF TRACKING AND TRENDING DATA FOR ARCHITECT CA 19-9XR REAGENT AND FOR LOT 81862FP00 DID NOT IDENTIFY ANY TRENDS RELATED TO THE ISSUE UNDER REVIEW. REVIEW OF THE DEVICE HISTORY RECORD OF THE COMPLAINT LOT 81862FP00 DID NOT FIND ANY NON-CONFORMANCES OR DEVIATIONS. ACCURACY TESTING WAS PERFORMED TO EVALUATE THE PERFORMANCE OF THE REAGENT LOT 81862FP00. AN INTERNAL CA 19-9XR PANEL WAS TESTED WITH RETAINED KITS OF THE COMPLAINT LOT. ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE OF THE LOT 81862FP00. LABELING WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT CA 19-9XR REAGENT LOT 81862FP00.
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 02K91-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02K91-33, CA 19-9 XR, WITH 510K NUMBER K052000.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT CA 19-9XR RESULT GENERATED FOR A PATIENT SAMPLE. IT IS UNKNOWN IF THE PATIENT HAS A HISTORY OF PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 0-37 U/ML): SAMPLE ID (B)(6) INITIAL RESULT = 196.24 U/ML, REPEAT RESULTS = 24.91 U/ML, 25.54 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.