ARCHITECT CA19-9XR
Received Jun 2, 2026 · Event occurred May 16, 2026
Report 3002809144-2026-00145 · MDR key 25361375
Device
Generic name
System, Test, Carbohydrate Ag (ca19-9), For Monit And Mgmt Of Pancreatic Cancer
Manufacturer
Abbott GmbhCatalog number
02K91-39
Lot number
82824FP00
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CA 19-9 RESULTS FOR ONE PATIENT WHO HAS PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2026, SID (B)(6) ARCHITECT CA 19-9 RESULT 51.81 U/ML. THE SAMPLE WAS CENTRIFUGED AND REPEATED SID (B)(6), RESULTS 0.00 / 0.15 / 0.10 U/ML. 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 02K91-39 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91-33, WITH 510K NUMBER K052000. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.