ALINITY I CA 19-9XR REAGENT KIT
Received May 1, 2026 · Event occurred Apr 13, 2026
Report 3002809144-2026-00114 · MDR key 25055326
Device
Generic name
System, Test, Carbohydrate Ag (ca19-9), For Monit And Mgmt Of Pancreatic Cancer
Manufacturer
Abbott GmbhCatalog number
08P32-20
Lot number
79770FP00
Product problems
- High Test Results
Patient
NA · 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 08P32-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08P32-21, WITH 510K/PMA/BLA NUMBER K052000.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA19-9XR RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2026, SID (B)(6): INITIAL RESULT = 49.13 U/ML, REPEATS = 8.51 U/ML, 10.07 U/ML, 9.01 U/ML, AND 9.60 U/ML HISTORICAL RESULT WAS AROUND 10 U/ML. THE 9.60 U/ML RESULT WAS REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN IF THE PATIENT WAS DIAGNOSED WITH PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.