MalfunctionDCF
TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATION
Received Jan 8, 2026 · Event occurred Dec 17, 2025
Report 1823260-2026-00107 · MDR key 24005357
Device
Generic name
Albumin Immunological Test System
Manufacturer
Roche DiagnosticsCatalog number
04469658190
Lot number
87306701
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER IS (B)(6) THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATION ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS INTEGRA 400 PLUS W/O ISE. THE INITIAL RESULT WAS 247.4 MG/L. THE REPEAT RESULT WAS 6.6 MG/L. THE REPEAT RESULT WAS DEEMED CORRECT BASED ON THE PATIENT'S MEDICAL HISTORY.