ELECSYS ANTI-TG
Received Jul 1, 2026 · Event occurred Jun 9, 2026
Report 1823260-2026-02652 · MDR key 25680586
Device
Generic name
Thyroid Autoantibody Test System
Manufacturer
Roche DiagnosticsCatalog number
09005021190
Lot number
87798201
Product problems
- High Test Results
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS ANTI-TG ASSAY RESULT FOR ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE RESULT IS >4000 IU/ML. THE REPORTER SUSPECTS AN INTERFERENT IN THE PATIENT SAMPLE. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY BECAUSE IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS.