ELECSYS CMV IGM
Received Jul 7, 2026 · Event occurred Nov 3, 2025
Report 1823260-2026-02736 · MDR key 25738165
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Roche DiagnosticsCatalog number
04784618190
Lot number
ASKU
Product problems
- False Negative Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CMV IGM AND ELECSYS CMV IGG ASSAY RESULTS FROM THREE PATIENT SAMPLES TESTED ON THE COBAS 6000 E601 MODULE. THIS MEDWATCH IS FOR THE ELECSYS CMV IGM ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS CMV IGG ASSAY REPORT. PLEASE REFER TO THE ATTACHMENT (B)(6) FOR THE TABLE CONTAINING THE QUESTIONABLE RESULTS AND OTHER INFORMATION REGARDING THE CASE.
Additional Manufacturer Narrative
THE COBAS 6000 E601 MODULE SERIAL NUMBER IS (B)(6).