ARTISAN GOMORI'S BLUE TRICHROME STAIN KIT
Received Oct 14, 2020 · Event occurred Sep 15, 2020
Report 2022180-2020-00358 · MDR key 10678730
Device
Generic name
Artisan Gomori's Blue Trichrome Stain Kit
Manufacturer
Dako North America Inc.Model number
AR167Catalog number
AR16792-2
Lot number
11161727
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ROOT CAUSE: ALTERATION OF ASSAY AND STAINING IN THIS CASE WAS NOT CONFIRMED. THE PROBLEM WAS INVESTIGATED BY A FIELD SERVICE ENGINEER. THIS INVESTIGATION DID NOT IDENTIFY ANY INSTRUMENT MALFUNCTION OR ALTERATION IN INSTRUMENT PERFORMANCE. THE INSTRUMENT REMAINS FULLY OPERATIONAL WITHIN SPECIFICATIONS, WITHOUT ERRORS AND AVAILABLE FOR THE USER. FAILURE MODE DESCRIPTION: AS NO MALFUNCTION WERE FOUND AFTER COMPLETION OF INVESTIGATION; THE FAILURE MODE COULD NOT BE VERIFIED AS AN INSTRUMENT OR PRODUCT SPECIFIC MALFUNCTION. THEREFORE, THIS REPORT IS BEING FILED AS PART OF AGILENT'S COMMITMENT TO DUE DILIGENCE REPORTING.
Description of Event or Problem
CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: INCONSISTENT STAINING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.
Remedial action
- Modification/Adjustment