ELECSYS CMV IGM
Received Apr 24, 2026 · Event occurred Apr 3, 2026
Report 1823260-2026-01596 · MDR key 24987409
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Roche DiagnosticsCatalog number
07027133190
Lot number
906582
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL SERUM SAMPLE RESULT WAS 1.71 COI (REACTIVE). THE SAMPLE WAS RECENTRIFUGED AND REPEATED AND THE RESULT WAS 1.67 COI (REACTIVE). A PLASMA SAMPLE COLLECTED AT THE SAME TIME WAS TESTED AND THE RESULT WAS 0.332 COI (NON-REACTIVE). ON EITHER 12-APR OR (B)(6) 2026, THE PLASMA SAMPLE WAS REPEATED AND THE RESULT WAS 0.626 COI (NON-REACTIVE). THE EXACT DATE OF TESTING WAS NOT PROVIDED. THE CUSTOMER DEEMED THE NON-REACTIVE RESULT AS CORRECT.