ALINITY I CA 19-9XR REAGENT KIT
Received Jun 1, 2026 · Event occurred May 12, 2026
Report 3002809144-2026-00144 · MDR key 25349668
Device
Generic name
System, Test, Carbohydrate Ag (ca19-9), For Monit And Mgmt Of Pancreatic Cancer
Manufacturer
Abbott GmbhCatalog number
08P32-20
Product problems
- High Test 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER (B)(4) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER (B)(4), 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: INITIAL RESULT WAS >1200 U/ML, REPEATS WITH AUTOMATIC 1:10 DILUTION AND MANUAL DILUTION WERE AROUND 800 TO 900 U/ML. IT IS UNKNOWN IF THE PATIENT WAS DIAGNOSED WITH PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.