ELECSYS CMV IGG
Received Jan 14, 2026 · Event occurred Dec 11, 2025
Report 1823260-2026-00175 · MDR key 24067106
Device
Generic name
Cytomegalovirus Immunoassay
Manufacturer
Roche DiagnosticsModel number
CMV IGGCatalog number
09118551190
Lot number
ASKU
Product problems
- False Negative Result
- Low Test Results
Patient
32 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A FALSE NEGATIVE ELECSYS CMV IGG RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. PLEASE SEE THE ATTACHMENT "(B)(6)" FOR THE PATIENT'S RESULTS.
Additional Manufacturer Narrative
THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE RESULTS OF THE INVESTIGATION: ELECSYS CMV IGM: 0.193 COI ->NON-REACTIVE. ELECSYS CMV IGG: 0.150 U/ML (<TEST) ->NON-REACTIVE. MIKROGEN RECOMLINE CMV IGG: NON-REACTIVE. PLATELIA CMV IGG: 0.97 COI ->INDETERMINATE. THE NON-REACTIVE ELECSYS CMV IGG RESULT WAS REPRODUCIBLE. EXTENSIVE ANALYSIS OF THE PATIENT SAMPLE SHOWED THAT THE NON-REACTIVE RESULT IS SUPPORTED BY IMMUNOBLOT TESTING AND CONSIDERED CORRECT. PER PRODUCT LABELING, "ELECSYS CMV IGG RESULTS SHOULD BE USED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL SYMPTOMS AND OTHER LABORATORY TESTS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative
A NEW SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2026, AND THE CMV IGG RESULT WAS <0.25 U/ML (NEGATIVE).