ELECSYS CMV IGG
Received Mar 9, 2026 · Event occurred Feb 2, 2026
Report 1823260-2026-00832 · MDR key 24552078
Device
Generic name
Cytomegalovirus Immunoassay
Manufacturer
Roche DiagnosticsModel number
CMV IGGCatalog number
09118551190
Lot number
878438
Product problems
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE POSITIVE ELECSYS CMV IGG RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2026: THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE COLLECTED ON (B)(6) 2026 WAS 7.69 U/ML (POSITIVE). ON (B)(6) 2026: THE REPEAT RESULT OF THE INITIAL PATIENT SAMPLE FROM ANOTHER ANALYZER WAS <0.150 U/ML WITH A DATA FLAG (NEGATIVE). ON (B)(6) 2026, A NEW SAMPLE WAS OBTAINED, AND THE RESULT FROM THE OTHER ANALYZER WAS <0.150 U/ML WITH A DATA FLAG (NEGATIVE).