inforMED
MalfunctionKPA

DAKO OMNIS 110

Received Apr 1, 2026 · Event occurred Mar 3, 2026

Report 3003423869-2026-00001 · MDR key 24760631

Device

Generic name

Automated Slide Stainer

Model number

GI300

Catalog number

GI30030

Product problems

  • Fumes or Vapors

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

A BELGIUM CUSTOMER REPORTED THAT A COMPETITORS FIELD SERVICE ENGINEER, FSE, WAS SERVICING A NON-AGILENT INSTRUMENT, AND OBSERVED A PINK DISCOLORATION ON THE FILTER AND ON A METALLIC COMPONENT NEAR OUR ADJACENT AGILENT OMNIS. THE CUSTOMER EXPRESSED CONCERN THAT DURING OMNIS WASTE DISPOSAL SOME WASTE, SPECIFICALLY DAB AND MAGENTA CHROMOGENS, MAY HAVE EVAPORATED AND BEEN DRAWN INTO THE ADJACENT COMPETITOR INSTRUMENT'S FILTER, AND AS A RESULT, DYED THE INSTRUMENT. IMAGES WERE PROVIDED BY THE CUSTOMER CONFIRMING THE COLOR CHANGE NOTED OF THE COMPETITOR INSTRUMENT. ADDITIONALLY, THE IMAGES SHOWED THAT THE CUSTOMER'S OMNIS HAZARDOUS WASTE HOSE LACKED ONE OF THE TWO REQUIRED COUPLINGS. THIS HOSE IS NOT ALIGNED WITH OUR VALIDATED PART AS THE HOSE MUST HAVE 2 COUPLINGS ATTACHED TO PROVIDE A SECURE CONNECTION TO THE HAZARDOUS WASTE CONTAINER. THIS EDITED PART AND ITS USAGE IS OUTSIDE OF THE INTENDED USE DESCRIBED IN THE USER MANUAL. NO HARM HAS BEEN REPORTED FOR THE EVENT. WHILE THERE WAS NO DIRECT, OR INDIRECT, USER HARM REPORTED FOR THIS EVENT; IT IS BEING REPORTED DUE TO THE POTENTIAL FOR HARM (POTENTIAL EXPOSURE TO HAZARDOUS WASTE, SEVERITY 4) IF THE EVENT WERE TO RECUR. THEREFORE, THIS REPORT IS BEING FILED AS PART OF AGILENT'S COMMITMENT TO DUE DILIGENCE REPORTING.

Description of Event or Problem

ON (B)(6) 2026, AGILENT CONFIRMED THAT THE HAZARDOUS WASTE TUBING AT CUSTOMER SITE WAS REPLACED WITH THE OMNIS RECOMMENDED HAZARDOUS WASTE HOSE WITH ATTACHED CONNECTORS/COUPLERS. ADDITIONALLY, APPROPRIATE, AND RECOMMENDED WASTE CONTAINERS WERE INSTALLED IN PLACE AS WELL. THE INSTRUMENT HAS BEEN TESTED AND CONFIRMED TO BE FULLY OPERATIONAL AND SUITABLE FOR USE PER AGILENT RECOMMENDATIONS AND STANDARDS.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION RECEIVED: THE FOLLOWING FIELDS WERE UPDATED: B4, B5, G1, G3, G6, H2, H3, H6, H11.