ALINITY I CA 19-9XR REAGENT KIT
Received Feb 16, 2026 · Event occurred Jan 26, 2026
Report 3002809144-2026-00039 · MDR key 24344980
Device
Generic name
System, Test, Carbohydrate Ag (ca19-9), For Monit And Mgmt Of Pancreatic Cancer
Manufacturer
Abbott GmbhCatalog number
08P32-20
Lot number
78765FP00
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I CA 19-9XR FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2026, SID (B)(6), INITIAL CA 19-9 RESULT= 38.64 U/ML, 164.32 U/ML (B)(6) 2026, REPEAT RESULT= 3.25 U/ML, 3.34 U/ML; REPEAT RESULT ON ANOTHER ANALYZER= 3.03 U/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I CA 19-9XR ASSAY DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, NO TRENDS WERE IDENTIFIED FOR LOT 78765FP00. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WHICH DID NOT SHOW ANY NON-CONFORMANCES, DEVIATIONS, OR POTENTIAL NON-CONFORMANCES FOR THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ALINITY I CA 19-9XR REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 78765FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CA 19-9XR REAGENT LOT 78765FP00 WAS IDENTIFIED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. 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, AND A 510K NUMBER OF K052000.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I CA 19-9XR FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2026, SID (B)(6), INITIAL CA 19-9 RESULT= 38.64 U/ML, 164.32 U/ML. ON (B)(6) 2026, REPEAT RESULT= 3.25 U/ML, 3.34 U/ML; REPEAT RESULT ON ANOTHER ANALYZER= 3.03 U/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.