Alinity i CA 19-9XR Reagent Kit
Received Jul 27, 2026 · Event occurred Jul 6, 2026
Report 3002809144-2026-00199 · MDR key 50034394
Device
Generic name
System, Test, Carbohydrate Ag (ca19-9), For Monit And Mgmt Of Pancreatic Cancer
Manufacturer
Abbott GmbhCatalog number
08P32-20
Lot number
85986FP00
Product problems
- Imprecise or Erratic Results
Patient
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 2 patients. The customers are not aware if patients were diagnosed with pancreatic cancer or any other cancer as do not have access since the samples are referred samples. The following data was provided:(b)(6) 2026, SID (b)(6); 56-year-old female; Initial result =41.42 U/mL, repeat result 69.73 U/mL.(b)(6) 2026, SID (b)(6), 60-year-old female; Initial result =61.14 U/mL, repeat result 103.53 U/mL.No additional information was available. 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.