MalfunctionLFZ
ELECSYS CMV IGG
Received Mar 3, 2026 · Event occurred Feb 12, 2026
Report 1823260-2026-00760 · MDR key 24500353
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Roche DiagnosticsModel number
CMV IGGCatalog number
09118543190
Lot number
878038
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE E411 ANALYZER SERIAL NUMBER WAS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS CMV IGG (CMV IGG) ON A COBAS E 411 ANALYZER (RACK SYSTEM). SAMPLE 1: THE INITIAL RESULT WAS <0.150 U/ML (NEGATIVE). THE REPEAT RESULT WAS 453.4 U/ML (POSITIVE). SAMPLE 2: THE INITIAL RESULT WAS <0.150 U/ML (NEGATIVE). THE REPEAT RESULT WAS > 500 U/ML (POSITIVE).