ELECSYS CMV IGG
Received Jan 15, 2026 · Event occurred Dec 23, 2025
Report 1823260-2026-00181 · MDR key 24077914
Device
Generic name
Cytomegalovirus Immunoassay
Manufacturer
Roche DiagnosticsModel number
CMV IGGCatalog number
09118551190
Lot number
87843800
Product problems
- False Positive Result
- High Test Results
- Non Reproducible Results
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E 801 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGG RESULTS FROM THE COBAS E 801 MODULE. THE INITIAL RESULT WAS 7.57 U/ML (REACTIVE). THE REPEAT RESULT WAS CONSISTENTLY 0.15 U/ML (NON-REACTIVE) UPON TESTING FIVE TIMES.
Additional Manufacturer Narrative
THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. A SAMPLE-SPECIFIC ISSUE COULD NTO BE EXCLUDED. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. A GENERAL REAGENT PROBLEM WAS NOT PRESENT BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.