ELECSYS TOXO IGG
Received Jun 11, 2026 · Event occurred May 18, 2026
Report 1823260-2026-02315 · MDR key 25476355
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Manufacturer
Roche DiagnosticsCatalog number
07028008190
Lot number
ASKU
Product problems
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E 402 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6) THE INVESTIGATION IS ONGOING.
Description of Event or Problem
ROCHE DIAGNOSTICS RECEIVED A CUSTOMER COMPLAINT REGARDING AN ALLEGED DISCREPANT ELECSYS TOXO IGG ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS PURE E 402 ANALYTICAL UNIT. THE SAME PATIENT'S SAMPLE ALIQUOT YIELDED 0.15 IU/ML ON A COBAS E 411, AND 4.30 IU/ML ON THE COMPETITOR DEVICE, WHILE IT YIELDED A NEGATIVE RESULT ON THE COBAS PURE E 402. A REACTIVE DISCREPANCY WAS ALSO REPORTED FOR THE SAME SAMPLE FOR ELECSYS TOXO IGM, BUT THE EXACT RESULTS WERE NOT PROVIDED.