ELECSYS CMV IGG
Received Nov 3, 2025 · Event occurred Aug 28, 2025
Report 1823260-2025-04458 · MDR key 23450692
Device
Generic name
Cytomegalovirus Immunoassay
Manufacturer
Roche DiagnosticsModel number
CMV IGGCatalog number
09118551190
Lot number
84805101
Product problems
- False Negative Result
- False Negative Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGG RESULTS WITH A PATIENT SAMPLE TESTED ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2025: THE RESULT WAS NON-REACTIVE. ON (B)(6) 2025: THE RESULT WAS 235 U/ML (REACTIVE).
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE, WITH THE MOST LIKELY CAUSE BEING THE HANDLING OF SAMPLES AT THE COLLECTION POINTS, AS WELL AS AN ISSUE WITH INDIVIDUAL TUBES, WHICH HAS NOW BEEN ADDRESSED. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. NO PRODUCT PROBLEM WAS IDENTIFIED.