ALINITY I CA 19-9XR REAGENT KIT
Received May 14, 2026 · Event occurred Mar 24, 2026
Report 3002809144-2026-00122 · MDR key 25176594
Device
Generic name
System, Test, Carbohydrate Ag (ca19-9), For Monit And Mgmt Of Pancreatic Cancer
Manufacturer
Abbott GmbhCatalog number
08P32-20
Lot number
83893FP00
Product problems
- Imprecise or Erratic Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED IMPRECISE RESULTS FOR THE ALINITY CA 19-9XR FOR 3 PATIENTS. CLINICAL HISTORY IS UNKNOWN FOR THE PATIENTS. THE FOLLOWING DATA WAS PROVIDED: 73-YEAR-OLD MALE MULTIPLE SAMPLES. CUSTOMER IS QUESTIONING THE RESULT FROM (B)(6) 2026: SID (B)(6) PROCESSED ON (B)(6) 2026 = 1034.27 U/ML SID (B)(6) PROCESSED ON (B)(6) 2026 = 270.59 U/ML SID (B)(6) PROCESSED ON (B)(6) 2026 = 236.94 U/ML HISTORICAL RESULTS: SID (B)(6) PROCESSED ON (B)(6) 2026 = 169.39 U/ML SID (B)(6) PROCESSED ON (B)(6) 2026 = 180.56 U/ML SID (B)(6) PROCESSED ON (B)(6) 2026 = 160.12 U/ML 25-YEAR-OLD FEMALE SID (B)(6) INITIAL RESULT = 40.82 REPEAT RESULT = 74.56 U/ML 63-YEAR-OLD FEMALE SID (B)(6) INITIAL RESULT = 57.31 REPEAT RESULT = 85.83 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
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. ALL AVAILABLE PATIENT INFORMATION WAS PROVIDED, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.