ARCHITECT CA19-9XR
Received Dec 22, 2025 · Event occurred Dec 17, 2025
Report 3002809144-2025-00404 · MDR key 23864048
Device
Generic name
System, Test, Carbohydrate Ag (ca19-9), For Monit And Mgmt Of Pancreatic Cancer
Manufacturer
Abbott GmbhCatalog number
02K91-39
Lot number
77713FP00
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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 2K91-39 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91 - 39, WITH 510K/PMA/BLA NUMBER K052000.
Description of Event or Problem
THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CA 19-9XR AND PROVIDED THE FOLLOWING DATA: ORIGINAL RESULT WAS >1200 ON LOT 77713FP00. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Additional Manufacturer Narrative
A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ARCHITECT CA19-9XR REAGENT, LOT 77713FP00. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ARCHITECT CA19-9XR REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. REVIEW SHOWS THE MEDIAN PATIENT RESULT FOR THE LOT IS WITHIN THE ESTABLISHED LIMITS, INDICATING THE LOT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE. BASED ON THE INVESTIGATION, THERE IS NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CA19-9XR REAGENT, LOT 77713FP00.
Description of Event or Problem
THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CA 19-9XR AND PROVIDED THE FOLLOWING DATA: ORIGINAL RESULT WAS >1200 ON LOT 77713FP00. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.