ELECSYS T4
Received Jun 5, 2026 · Event occurred May 11, 2026
Report 1823260-2026-02236 · MDR key 25410985
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsModel number
T4Catalog number
09007784190
Lot number
87795901
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 IS NOT AVAILABLE FOR INVESTIGATION.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE THYROID ASSAY RESULTS FOR ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE ELECSYS T4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER: (B)(6) FOR THE ELECSYS FT4 IV ASSAY. (B)(6) FOR THE ELECSYS T3 ASSAY. (B)(6) FOR THE ELECSYS FT3 III ASSAY. AN INTERFERENT IS SUSPECTED FOR THESE ASSAYS. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER: (B)(6) - FOR THE QUESTIONABLE ELECSYS ANTI-TPO ASSAY RESULTS. PLEASE REFER TO THE ATTACHMENT (B)(6) IN THE MEDWATCH FOR THE TABLE CONTAINING THE QUESTIONABLE RESULTS FROM THE ANALYZER COMPARED WITH THE ASSAY RESULTS FROM A BECKMANN ANALYZER.