Alinity i CA 19-9XR Reagent Kit
Received Jun 30, 2026 · Event occurred Jun 20, 2026
Report 3002809144-2026-00174 · MDR key 25667814
Device
Generic name
System, Test, Carbohydrate Ag (ca19-9), For Monit And Mgmt Of Pancreatic Cancer
Manufacturer
Abbott GmbhCatalog number
08P32-77
Lot number
83892FP01
Product problems
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. 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 8P32-77 HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21/-31.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA19-9XR RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): HISTORICAL RESULT = 48 U/ML, RETEST RESULTS = 103.2 U/ML AND 91.03 U/ML. ADDITIONAL DATA WAS PROVIDED: 67.57 U/ML, 75.45 U/ML, AND 72.12 U/ML. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.