ELECSYS RUBELLA IGG
Received May 18, 2026 · Event occurred Apr 24, 2026
Report 1823260-2026-01938 · MDR key 25201979
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Rubella
Manufacturer
Roche DiagnosticsCatalog number
07027770190
Lot number
927766
Product problems
- Incorrect Measurement
Patient
Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS LATER CONFIRMED THAT THE INITIAL RESULT WAS 20.6 IU/ML. THE PROVIDED RESULT OF 19.1 IU/ML WAS INCORRECT.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE POSITIVE ELECSYS RUBELLA IGG ASSAY RESULT FOR ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 MODULE. THE INITIAL RESULT WAS 19.1 IU/ML (POSITIVE). A RESULT OF 20.6 IU/ML (POSITIVE) WAS ALSO PROVIDED. THE REPEAT RESULT AT AN EXTERNAL LABORATORY USING THE DIASORIN LIAISON, WHICH USES THE ENZYME IMMUNOASSAY (EIA) LABORATORY METHOD, WAS 5.54 IU/ML (NEGATIVE). ON (B)(6) 2026, THE REPEAT RESULT USING A SECOND ALIQUOT OF THE SAMPLE WAS 19.8 IU/ML.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER IS (B)(6). SAMPLE MATERIAL WAS PROVIDED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.