ALINITY I CA 19-9XR REAGENT KIT
Received Dec 9, 2025 · Event occurred Nov 21, 2025
Report 3002809144-2025-00388 · MDR key 23755235
Device
Generic name
System, Test, Carbohydrate Ag (ca19-9), For Monit And Mgmt Of Pancreatic Cancer
Manufacturer
Abbott GmbhCatalog number
08P32-30
Lot number
76656FP00
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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P32-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21, WITH 510K/PMA/BLA NUMBER K052000.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA 19-9XR RESULT ON A PATIENT. RESULTS PROVIDED: >1200 / AUTODILUTION = 500 U/ML. IT IS UNKNOWN WHETHER THE PATIENT HAS PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I CA 19-9XR REAGENT LOT 76656FP00. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. HISTORICAL PERFORMANCE OF REAGENT LOT 76656FP00 EVALUATED USING WORLDWIDE FIELD DATA FOR THE ALINITY I CA 19-9XR ASSAY. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THE PATIENT MEDIANS WERE WITHIN THE ESTABLISHED LIMITS, INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY IN THE FIELD. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I CA 19-9XR REAGENT LOT 76656FP00.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA 19-9XR RESULT ON A PATIENT. RESULTS PROVIDED: >1200 / AUTODILUTION = 500 U/ML. IT IS UNKNOWN WHETHER THE PATIENT HAS PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.