ARCHITECT CA19-9XR
Received Jun 10, 2026 · Event occurred Mar 13, 2026
Report 3002809144-2026-00151 · MDR key 25457342
Device
Generic name
System, Test, Carbohydrate Ag (ca19-9), For Monit And Mgmt Of Pancreatic Cancer
Manufacturer
Abbott GmbhCatalog number
02K91-39
Lot number
78761FP00
Product problems
- Imprecise or Erratic Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or Problem
THE CUSTOMER OBSERVED IMPRECISE ARCHITECT CA 19-9XR RESULTS FOR ONE PATIENT BETWEEN LOT NUMBERS. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), PROCESSED ON (B)(6) 2026 REAGENT LOT 78761FP00 RESULT = 466.44 SID (B)(6), PROCESSED ON (B)(6) 2026 REAGENT LOT 80822FP00 RESULT = 123 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.