ELECSYS CMV IGG
Received Mar 6, 2026 · Event occurred Dec 1, 2025
Report 1823260-2026-00810 · MDR key 24537066
Device
Generic name
Cytomegalovirus Immunoassay
Manufacturer
Roche DiagnosticsModel number
CMV IGGCatalog number
09118551190
Lot number
878438
Product problems
- Low Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGG RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. ON AN UNKNOWN DATE IN (B)(6), THE RESULT VIA DIASORIN METHOD WAS POSITIVE. ON (B)(6) 2025, THE CMV IGG RESULT USING THE CUSTOMER'S ROCHE METHOD WAS NEGATIVE. ON (B)(6) 2026, THE RESULT FROM THE COBAS E801 WAS NEGATIVE. ON (B)(6) 2026, A NEW SAMPLE WAS DRAWN, AND THE RESULT USING THE COBAS E801 WAS NEGATIVE. ON (B)(6) 2026, THE RESULT FROM THE COBAS E801 WAS NEGATIVE. ALIQUOTS OF THE PATIENT SAMPLE WERE RETESTED AT OTHER CENTERS USING DIFFERENT METHODS: THE DIASORIN RESULT WAS POSITIVE. THE RESULT FROM ANOTHER ROCHE SYSTEM WAS POSITIVE.
Additional Manufacturer Narrative
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.