MalfunctionNJT
ULTRAVIEW UNIVERSAL DAB DETECTION KIT
Received Jun 29, 2026 · Event occurred Jun 8, 2026
Report 2028492-2026-02600 · MDR key 25659392
Device
Generic name
Immunohistochemistry Reagents And Kits
Manufacturer
Ventana Medical Systems Inc.Catalog number
05269806001
Lot number
N12393
Product problems
- False Negative Result
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE CK7 RESULTS FOR A PATIENT SAMPLE TESTED USING THE ULTRAVIEW UNIVERSAL DAB DETECTION KIT AND THE BENCHMARK ULTRA SYSTEM. THE INITIAL RESULT WAS NEGATIVE FOR CK7. THE PARAFFIN BLOCK WAS SENT TO A HIGHER-LEVEL HOSPITAL FOR CONSULTATION, WHERE THE CK7 STAINING WAS POSITIVE.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.