ELECSYS TOXO IGG
Received Jun 24, 2026 · Event occurred May 22, 2026
Report 1823260-2026-02501 · MDR key 25606608
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Manufacturer
Roche DiagnosticsCatalog number
04618815190
Lot number
86681601
Product problems
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES TESTED WITH ELECSYS TOXO IGG ASSAY ON A COBAS E 411 ANALYZER (DISK SYSTEM). PATIENT 1: INITIAL RESULT: 0.926 IU/ML. REPEAT RESULT: 650 IU/ML (ACCOMPANIED BY A DATA FLAG). PATIENT 2: INITIAL RESULT: 0.452 IU/ML. REPEAT RESULT: 176.02 IU/ML. PATIENT 3: INITIAL RESULT: 0.800 IU/ML. REPEAT RESULT: 650 IU/ML (ACCOMPANIED BY A DATA FLAG).
Additional Manufacturer Narrative
THE COBAS E 411 ANALYZER (DISK SYSTEM) SERIAL NUMBER WAS (B)(6). THE QC WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.