ALINITY I CEA REAGENT KIT
Received Jun 4, 2026 · Event occurred May 25, 2026
Report 3008344661-2026-00085 · MDR key 25392411
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P62-20
Lot number
78036FZ00
Product problems
- Low Test Results
Patient
71 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY DECREASED ALINITY I CEA (CARCINOEMBRYONIC ANTIGEN) RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR A 71-YEAR-OLD FEMALE PATIENT. THE CUSTOMER STATED IT RAN THE SAME SAMPLE TUBE 4 TIMES ACROSS TWO ANALYZERS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: < 5 NG/ML): ON (B)(6) 2026, SID (B)(6). RESULTS ON (B)(6): FIRST RUN: < 0.5 NG/ML THIRD RUN: 30.31 NG/ML. RESULTS ON (B)(6): SECOND RUN: 29.29 NG/ML FOURTH RUN: 29.09 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.