ELECSYS CMV IGG
Received Sep 16, 2025
Report 1823260-2025-02934 · MDR key 23066036
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Roche DiagnosticsModel number
CMV IGGCatalog number
09118543190
Lot number
657960
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A GENERAL REAGENT PROBLEM CAN BE EXCLUDED. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: NO FOLLOW UP ACTIONS TAKEN. 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?" NO. 5. DEVICE REPROCESSED AND REUSED? NO.
Description of Event or Problem
1. DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR TWO PATIENTS TESTED WITH ELECSYS CMV IGG ON A COBAS 6000 E601 MODULE.