ELECSYS CMV IGG
Received Dec 11, 2025 · Event occurred Oct 24, 2025
Report 1823260-2025-05055 · MDR key 23778187
Device
Generic name
Cytomegalovirus Immunoassay
Manufacturer
Roche DiagnosticsModel number
CMV IGGCatalog number
09118551190
Lot number
848051
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E 801 MODULE SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER AND FOUND NO ISSUES. 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 RESULT FOR A DONOR SAMPLE MEASURED ON (B)(6) 2025, HAD A RESULT OF < 0.150 U/ML WITH A DATA FLAG (NON-REACTIVE). TESTING OF BOTH EXISTING RETENTION SAMPLES FROM THE SAME DONOR/SAME DRAW HAD A RESULT OF > 500 U/ML WITH A DATA FLAG (REACTIVE). THE REPEAT RESULT WAS EXPECTED DUE TO EARLIER SCREENING RESULTS FOR THIS DONOR.
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THE INVESTIGATION WAS UNABLE TO EXCLUDE PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT BECAUSE THE QC BEFORE THE EVENT WAS WITHIN RANGES. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.