MalfunctionLFX
ELECSYS RUBELLA IGG
Received Apr 22, 2026 · Event occurred Mar 31, 2026
Report 1823260-2026-01548 · MDR key 24956932
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Rubella
Manufacturer
Roche DiagnosticsCatalog number
07027770190
Lot number
86531401
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS RUBELLA IGG RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 16.1 IU/ML(REACTIVE). ON (B)(6) 2026, THE REPEAT RESULTS USING REAGENT LOT 893040 WERE 8.73 IU/ML AND 8.90 IU/ML (NON-REACTIVE). ON (B)(6) 2026, THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR CONFIRMATION TESTING, AND THE RESULT WAS POSITIVE.