ELECSYS RUBELLA IGG
Received Mar 25, 2026 · Event occurred Jan 27, 2026
Report 1823260-2026-01069 · MDR key 24686330
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Rubella
Manufacturer
Roche DiagnosticsCatalog number
07027770190
Lot number
893040
Product problems
- High Test Results
Patient
37 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MEDWATCH FIELD D4 LOT NO WAS UPDATED. TWO ADDITIONAL PATIENT SAMPLES WERE REPORTED BY THE CUSTOMER, SHOWING DISCREPANT REACTIVE ELECSYS RUBELLA IGG RESULTS: SAMPLE 4: ON (B)(6) 2026, THE INITIAL RESULT WAS 45.4 IU/ML (POSITIVE). THE REPEAT RESULT AT A REFERENCE LAB WAS NEGATIVE. SAMPLE 4: ON (B)(6) 2026, THE INITIAL RESULT WAS 13.1 IU/ML (POSITIVE). THE REPEAT RESULT AT A REFERENCE LAB WAS NEGATIVE. THE TEST USED BY THE REFERENCE LAB WAS THE ABBOTT ALINITY RUBELLA IGG.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS RUBELLA IGG RESULTS FOR THREE PATIENT SAMPLES TESTED ON A COBAS E 402 ANALYTICAL UNIT COMPARED TO A REFERENCE LAB. SAMPLE 1: THE INITIAL RESULT WAS 40.5 IU/ML (POSITIVE). THE REPEAT RESULT AT A REFERENCE LAB WAS NEGATIVE. SAMPLE 2: THE INITIAL RESULT WAS 45 IU/ML (POSITIVE). THE REPEAT RESULT AT A REFERENCE LAB WAS NEGATIVE. SAMPLE 3: THE INITIAL RESULT WAS 46.2 IU/ML (POSITIVE). THE REPEAT RESULT AT A REFERENCE LAB WAS NEGATIVE.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.