ALINITY I CA 19-9XR REAGENT KIT
Received Jan 12, 2026 · Event occurred Dec 19, 2025
Report 3002809144-2026-00006 · MDR key 24039367
Device
Generic name
System, Test, Carbohydrate Ag (ca19-9), For Monit And Mgmt Of Pancreatic Cancer
Manufacturer
Abbott GmbhCatalog number
08P32-20
Lot number
77707FP00
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL 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 77707FP00. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR LOT 77707FP00 WHICH DID NOT SHOW ANY NON-CONFORMANCES, DEVIATIONS, OR POTENTIAL NON-CONFORMANCES. 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 77707FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I CA 19-9XR ASSAY FOR LOT 77707FP00 WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I CA 19-9XR FOR TWO PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED: (B)(6) 2025, SID (B)(6), INITIAL CA 19-9 RESULT= 78.11 U/ML; REPEAT RESULT= < 2.06 U/ML. (B)(6) 2025, SID (B)(6), INITIAL CA 19-9 RESULT= 37.08 U/ML; REPEAT RESULT= 9.33 U/ML . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
SECTION A1 - PATIENT IDENTIFIER: SAMPLE ID = (B)(6). 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 8P32-21, WITH 510K/PMA/BLA NUMBER K052000.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I CA 19-9XR FOR TWO PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED: (B)(6) 2025, SID (B)(6), INITIAL CA 19-9 RESULT= 78.11 U/ML; REPEAT RESULT= < 2.06 U/ML. (B)(6) 2025, SID (B)(6), INITIAL CA 19-9 RESULT= 37.08 U/ML; REPEAT RESULT= 9.33 U/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.