Dako CoverStainer CS100Recalls & reported problems
Agilent Technologies Singapore Pte Ltd · Dako CoverStainer · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dako CoverStainer is an automated slide stainer. Most of the 134 reports describe the lower door cracking or breaking and shock absorbers that do not hold the door open, and some mention a fluid spill from disconnected tubing. There are no deaths or injuries, and reports fell from 46 in the previous 12 months to 2 in the latest 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 135
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 05700571112571), received between Jul 7, 2023 and Sep 22, 2026 — classified as 135 malfunctions.
The most frequently reported specific device problem is “Break” (128 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break128
- Structural Problem123
- Device Fell6
- Mechanical Problem4
- Detachment of Device or Device Component2
- Adverse Event Without Identified Device or Use Problem1
- Connection Problem1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions131
- Bruise/Contusion2
- Electric Shock1
- Insufficient Information1
- Laceration(s)1
- Swelling/ Edema1
Recent adverse event reports
The 25 most recent of 135 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Insufficient Information
MAUDE report 50859895 ↗MalfunctionDec 12, 2025Break; Structural Problem; Break; Structural Problem
IT HAS BEEN REPORTED BY THE BRAZIL CUSTOMER THAT THE LOWER DOOR TO THE COVERSTAINER WAS BROKEN. THE CUSTOMER CLARIFIED WITH THE AGILENT FIELD SERVICE ENGINEER (FSE) THAT THE LOWER DOOR CRACKED NEAR THE SUPPORT IN THE UPPER CORNER AND WAS DISCARDED SEVERAL MONTHS EARLIER. THE FSE INSTALLED THE NEW LOWER DOOR, AND THE LOWER GAS SPRING SUPPORTS ON THE INSTRUMENT. THE INSTRUMENT HAS BEEN REPAIRED; IT IS FULLY OPERATIONAL AND IS AVAILABLE TO THE USER. THE CUSTOMER WAS ABLE TO COMPLETE STAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23791625 ↗MalfunctionNov 21, 2025Mechanical Problem; Device Fell; Mechanical Problem; Device Fell
THE BRAZIL CUSTOMER REPORTED THAT THE DAKO COVERSTAINER LOWER DOOR'S SHOCK ABSORBERS, WHICH ARE USED TO SUPPORT THE DOOR, OCCASIONALLY DESCENDED WHEN IT WAS OPENED. THE AGILENT REPRESENTATIVE REPORTED THAT THE SHOCK ABSORBERS WERE NOT REPLACED DURING THE PREVIOUS PREVENTIVE MAINTENANCE AS THEY WERE OUT OF STOCK LOCALLY AT THE TIME OF SERVICE. UPON RECEIPT OF THE SHOCK ABSORBERS IN INVENTORY, THE FIELD SERVICE ENGINEER (FSE) PERFORMED THE SERVICE AND REPLACED THE SHOCK ABSORBERS ON THE INSTRUMENT. THE INSTRUMENT HAS BEEN REPAIRED; IT IS FULLY OPERATIONAL AND IS AVAILABLE TO THE USER. THIS ISSUE DOES NOT AFFECT THE UTILITY OF THE INSTRUMENT, AND THE CUSTOMER WAS ABLE TO COMPLETE STAINING. USER HARM WAS NOT INDICATED OR REPORTED. WHILE THERE WAS NO DIRECT, OR INDIRECT, USER HARM REPORTED FOR THIS EVENT; IT IS BEING REPORTED DUE TO THE POTENTIAL FOR HARM IF THE EVENT WERE TO REOCCUR. THEREFORE, THIS REPORT IS BEING FILED AS PART OF AGILENT'S COMMITMENT TO DUE DILIGENCE REPORTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617647 ↗MalfunctionOct 30, 2025Mechanical Problem; Device Fell; Mechanical Problem; Device Fell
THE BRAZIL CUSTOMER REPORTED THAT THE RECENTLY INSTALLED DAKO COVERSTAINER LOWER DOORS SHOCK ABSORBERS, WHICH ARE USED TO SUPPORT THE DOOR, DID "NOT SUPPORT THE DOOR PROPERLY." CLARIFICATION WAS RECEIVED FROM THE AGILENT REPRESENTATIVE NOTING THAT THE SHOCK ABSORBERS DID NOT HAVE SUFFICIENT FORCE TO SECURELY HOLD THE DOOR OPEN PARTICULARLY DURING REAGENT BOTTLE CHANGES. USER HARM WAS NOT INDICATED OR REPORTED. THE FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND REPLACED THE SHOCK ABSORBERS. THE INSTRUMENT HAS BEEN REPAIRED; IT IS FULLY OPERATIONAL AND IS AVAILABLE TO THE USER. THIS ISSUE DOES NOT AFFECT THE UTILITY OF THE INSTRUMENT, AND THE CUSTOMER WAS ABLE TO COMPLETE STAINING. WHILE THERE WAS NO DIRECT, OR INDIRECT, USER HARM REPORTED FOR THIS EVENT; IT IS BEING REPORTED DUE TO THE POTENTIAL FOR HARM IF THE EVENT WERE TO REOCCUR. THEREFORE, THIS REPORT IS BEING FILED AS PART OF AGILENT'S COMMITMENT TO DUE DILIGENCE REPORTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23429780 ↗MalfunctionSep 5, 2025Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem
IT WAS REPORTED TO A FIELD SERVICE ENGINEER THAT THERE WAS A SPILL OF NON-HAZARDOUS WASTE LIQUID ONTO THE CUSTOMER'S LABORATORY COUNTER WHEN TUBING ON THE SIDE OF THE AUTOSTAINER INSTRUMENT DISCONNECTED. THE TUBING LOCKS INTO THE DEVICE BUT WAS DISCONNECTED FOR UNKNOWN REASONS CAUSING THE SPILL OF FLUID ONTO THE COUNTER AND ONTO THEIR POWER STRIP WHILE PLUGGED INTO THE ELECTRICAL OUTLET. PREVIOUS SERVICE VISITS CONFIRMED THE TUBING WAS LOCKED IN PLACE. THE TECHNICIAN PANICKED AND BEGAN TO WIPE THE LIQUID FROM THE POWER STRIP WHILE NOT WEARING GLOVES OR PERSONAL PROTECTIVE EQUIPMENT. THE TECHNICIAN FELT A SLIGHT ELECTRIC SHOCK AND EXPERIENCED A BRIEF TINGLING SENSATION IN THEIR HAND. FOLLOWING THE SHOCK, THE TECHNICIAN WAS SEEN BY A HEALTHCARE PROFESSIONAL AS A PRECAUTION, WITHOUT ANY ISSUES NOTED AND NO MEDICAL TREATMENT WAS ADMINISTERED. FOLLOW-UP INFORMATION ALSO CONFIRMED THAT NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO OTHER INFORMATION WAS PROVIDED ON HOW THE TUBING BECAME UNLOCKED, AND THE DEVICE REMAINS FULLY OPERATIONAL. THE AUTOSTAINER BASIC USER GUIDE PROVIDES CLEAR SAFETY INSTRUCTIONS INCLUDING BOTH: "EYE PROTECTION AND GLOVES MUST BE WORN WHEN H
Patient problems: Electric Shock
MAUDE report 22986914 ↗MalfunctionAug 13, 2025Break; Structural Problem; Break; Structural Problem
IT WAS REPORTED THAT AN AGILENT FIELD SERVICE ENGINEER WAS ONSITE FOR AN UNRELATED ISSUE AND FOUND THAT THE LOWER DOOR OF THE COVERSTAINER WAS CRACKED. THE PICTURE PROVIDED BY THE FIELD SERVICE ENGINEER SHOWS A CRACK AT THE UPPER CORNER OF THE LOWER DOOR CONFIRMING THE REPORTED ISSUE. THE FIELD SERVICE ENGINEER SERVICED THE INSTRUMENT WITH REPLACEMENT OF THE LOWER DOOR. THE INSTRUMENT IS FULLY OPERATIONAL AND READY FOR USE. THE CUSTOMER WAS ABLE TO COMPLETE STAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22792823 ↗MalfunctionAug 1, 2025Break; Structural Problem; Break; Structural Problem
IT WAS REPORTED THAT AN AGILENT FIELD SERVICE ENGINEER WAS ONSITE FOR AN UNRELATED ISSUE AND FOUND THAT THE LOWER DOOR OF THE COVERSTAINER WAS CRACKED. THE PICTURE PROVIDED BY THE FIELD SERVICE ENGINEER SHOWS A CRACK AT THE UPPER LEFT CORNER OF THE LOWER DOOR CONFIRMING THE REPORTED ISSUE. THE FIELD SERVICE ENGINEER SERVICED THE INSTRUMENT WITH REPLACEMENT OF THE LOWER DOOR AND SHOCK ABSORBERS. THE INSTRUMENT IS FULLY OPERATIONAL AND READY FOR USE. THE CUSTOMER WAS ABLE TO COMPLETE STAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22687043 ↗MalfunctionJul 21, 2025Break; Structural Problem; Break; Structural Problem
THE ITALY CUSTOMER REPORTED THAT THE LOWER DOOR OF THE COVERSTAINER CRACKED. THE PROVIDED PICTURE SHOWS THAT THE TOP CORNER OF THE DOOR HAS DEVELOPED A CRACK CONFIRMING CUSTOMER'S ISSUE. FIELD SERVICE ENGINEER SERVICED THE INSTRUMENT AND REPLACED THE LOWER DOOR AND SHOCK ABSORBERS. THE INSTRUMENT IS FULLY OPERATIONAL AND READY FOR USE. THE CUSTOMER WAS ABLE TO COMPLETE STAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22560150 ↗MalfunctionJun 18, 2025Break; Structural Problem; Break; Structural Problem
THE BRAZIL CUSTOMER REPORTED "BROKEN DOOR" FOR THE COVERSTAINER INSTRUMENT. IT WAS CONFIRMED THAT WHEN THE CUSTOMER TRIED TO CLOSE THE LOWER DOOR, THE DOOR BROKE AND DETACHED IN THE UPPER CORNER. THE FIELD SERVICE ENGINEER (FSE) IS SCHEDULED TO SERVICE THE INSTRUMENT. IN THE MEANTIME, THE CUSTOMER HAS REMOVED THE LOWER DOOR OF THE COVERSTAINER. AGILENT HAS INFORMED THE CUSTOMER NOT TO USE THE INSTRUMENT WITHOUT A LOWER DOOR. TESTING WAS ABLE TO BE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22287112 ↗MalfunctionMay 15, 2025Break; Structural Problem; Break; Structural Problem
THE UNITED KINGDOM CUSTOMER REPORTED THE LOWER DOOR OF THE COVERSTAINER INSTRUMENT HAS BROKEN IN THE TOP LEFT HAND CORNER. A PICTURE PROVIDED SHOWS THE TOP LEFT CORNER OF THE LOWER DOOR IS CRACKED. IT WAS CONFIRMED THERE WERE NO INJURIES. AGILENT ADVISED THE CUSTOMER TO TAKE THE INSTRUMENT OUT OF USE AS A PRECAUTION WHILE AWAITING REPAIR. THE CUSTOMER HAS AN ALTERNATE COVERSTAINER AVAILABLE TO COMPLETE TESTING IN THE INTERIM. THE AGILENT FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND REPLACED THE LOWER DOOR AND SHOCK ABSORBERS. ADDITIONALLY, THE FSE INSTALLED THE UPGRADED HINGE TO PREVENT FURTHER OCCURRENCES OF THIS ISSUE. THE INSTRUMENT IS FULLY OPERATIONAL AND READY FOR USE. TESTING WAS ABLE TO BE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22031103 ↗MalfunctionMay 9, 2025Break; Structural Problem; Break; Structural Problem
IT HAS BEEN REPORTED BY THE CHINA CUSTOMER THAT THE LOWER DOOR TO THE COVERSTAINER WAS BROKEN. IMAGES ARE AVAILABLE CONFIRMING THE DOOR IS CRACKED IN THE UPPER CORNER. THE FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND CONFIRMED THAT THE LOWER DOOR WAS BROKEN. THE FSE SERVICED THE INSTRUMENT AND REPLACED THE LOWER DOOR. THE INSTRUMENT HAS BEEN REPAIRED, IT IS FULLY OPERATIONAL AND IS AVAILABLE TO THE USER. THE CUSTOMER WAS ABLE TO COMPLETE STAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21993127 ↗MalfunctionMay 2, 2025Break; Structural Problem; Break; Structural Problem
IT HAS BEEN REPORTED BY THE CHINA CUSTOMER THAT THE LOWER DOOR TO THE COVERSTAINER WAS BROKEN. IMAGES ARE AVAILABLE CONFIRMING THE DOOR IS BROKEN IN THE UPPER AND LOWER CORNERS. THE FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND CONFIRMED THAT THE LOWER DOOR WAS BROKEN. THE FSE SERVICED THE INSTRUMENT AND REPLACED THE LOWER DOOR. THE INSTRUMENT HAS BEEN REPAIRED, IT IS FULLY OPERATIONAL AND IS AVAILABLE TO THE USER. THE CUSTOMER WAS ABLE TO COMPLETE STAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21952821 ↗MalfunctionMay 2, 2025Break; Structural Problem; Break; Structural Problem
THE CHINA CUSTOMER REPORTED THE LOWER DOOR OF THE COVERSTAINER INSTRUMENT WAS BROKEN. A PICTURE WAS PROVIDED SHOWING THE TOP CORNER OF THE LOWER DOOR WAS CRACKED. THE AGILENT FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND REPLACED THE LOWER DOOR AND HINGES. THE INSTRUMENT IS FULLY OPERATIONAL AND READY FOR USE. TESTING WAS ABLE TO BE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21950277 ↗MalfunctionMay 1, 2025Break; Structural Problem; Break; Structural Problem
IT HAS BEEN REPORTED BY THE CHINA CUSTOMER THAT THE LOWER DOOR TO THE COVERSTAINER WAS BROKEN. IMAGES ARE AVAILABLE CONFIRMING THE DOOR IS BROKEN IN THE UPPER CORNER. THE FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND CONFIRMED THAT THE LOWER DOOR WAS BROKEN. THE FSE SERVICED THE INSTRUMENT AND REPLACED THE LOWER DOOR. THE INSTRUMENT HAS BEEN REPAIRED, IT IS FULLY OPERATIONAL AND IS AVAILABLE TO THE USER. THE CUSTOMER WAS ABLE TO COMPLETE STAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21945839 ↗MalfunctionApr 30, 2025Break; Structural Problem; Break; Structural Problem
THE SWEDEN CUSTOMER REPORTED THAT THE COVER STAINER LOWER DOOR WAS BROKEN. THE FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND CONFIRM THAT THE UPPER CORNER OF THE LOWER DOOR WAS CRACKED. THE FSE SERVICED THE INSTRUMENT AND REPLACED THE LOWER DOOR AND SHOCK ABSORBERS. THE INSTRUMENT HAS BEEN REPAIRED, IT IS FULLY OPERATIONAL AND IS AVAILABLE TO THE USER. THE CUSTOMER WAS ABLE TO COMPLETE STAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21939470 ↗MalfunctionApr 30, 2025Break; Structural Problem; Break; Structural Problem
THE CHINA CUSTOMER REPORTED THE LOWER DOOR OF THE COVERSTAINER INSTRUMENT WAS BROKEN. A PICTURE WAS PROVIDED SHOWING THE TOP CORNER OF THE LOWER DOOR WAS CRACKED. THE AGILENT FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND REPLACED THE LOWER DOOR. THE INSTRUMENT IS FULLY OPERATIONAL AND READY FOR USE. TESTING WAS ABLE TO BE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21934226 ↗MalfunctionApr 30, 2025Break; Structural Problem; Break; Structural Problem
IT HAS BEEN REPORTED BY THE CHINA CUSTOMER THAT THE LOWER DOOR TO THE COVERSTAINER WAS BROKEN IN THE UPPER CORNER. IMAGES ARE AVAILABLE CONFIRMING THE ISSUE. THE FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND CONFIRMED THAT THE LOWER DOOR WAS BROKEN. THE FSE SERVICED THE INSTRUMENT AND REPLACED THE LOWER DOOR. THE INSTRUMENT HAS BEEN REPAIRED; IT IS FULLY OPERATIONAL AND IS AVAILABLE TO THE USER. THE CUSTOMER WAS ABLE TO COMPLETE STAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21934107 ↗MalfunctionApr 24, 2025Break; Structural Problem; Break; Structural Problem
IT HAS BEEN REPORTED BY THE DENMARK CUSTOMER THAT THE LOWER DOOR TO THE COVERSTAINER WAS CRACKED IN THE UPPER CORNER. IMAGES ARE AVAILABLE. THE FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND CONFIRMED THAT THE LOWER DOOR WAS CRACKED. FSE SERVICED THE INSTRUMENT AND REPLACED THE LOWER DOOR. THE INSTRUMENT HAS BEEN REPAIRED, IT IS FULLY OPERATIONAL AND IS AVAILABLE TO THE USER. THE CUSTOMER WAS ABLE TO COMPLETE STAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21902300 ↗MalfunctionApr 21, 2025Break; Structural Problem; Break; Structural Problem
IT HAS BEEN REPORTED BY THE SOUTH KOREA CUSTOMER THAT THE LOWER DOOR TO THE OVERSTAIN WAS BROKEN. IMAGES WERE REQUESTED BUT WERE NOT AVAILABLE. THE FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND CONFIRMED THAT THE LOWER DOOR WAS CRACKED. FSE SERVICED THE INSTRUMENT AND REPLACED THE LOWER DOOR. THE INSTRUMENT HAS BEEN REPAIRED, IT IS FULLY OPERATIONAL AND IS AVAILABLE TO THE USER.. THE CUSTOMER WAS ABLE TO COMPLETE STAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21874875 ↗MalfunctionApr 17, 2025Break; Structural Problem; Break; Structural Problem
THE ITALY CUSTOMER REPORTED THE LOWER DOOR FOR THE COVERSTAINER INSTRUMENT WAS CRACKED. A PICTURE WAS PROVIDED SHOWING THE CORNER OF THE LOWER DOOR IS CRACKED. THE AGILENT FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND REPLACED THE LOWER DOOR AND SHOCK ABSORBERS. THE INSTRUMENT IS FULLY OPERATIONAL AND READY FOR USE. TESTING WAS ABLE TO BE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21857422 ↗MalfunctionMar 18, 2025Mechanical Problem; Device Fell; Mechanical Problem; Device Fell
THE CUSTOMER FROM SPAIN HAS REPORTED THAT THE LOWER DOOR OF THE COVER STAINER CANNOT REMAIN OPEN DUE TO SHOCK ABSORBER FAILURE. USER HARM WAS NOT INDICATED OR REPORTED. THE FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND REPLACED THE SHOCK ABSORBERS. THE INSTRUMENT HAS BEEN REPAIRED, IT IS FULLY OPERATIONAL AND IS AVAILABLE TO THE USER. THIS ISSUE DOES NOT AFFECT THE UTILITY OF THE INSTRUMENT, AND THE CUSTOMER WAS ABLE TO COMPLETE STAINING. WHILE THERE WAS NO DIRECT, OR INDIRECT, USER HARM REPORTED FOR THIS EVENT; IT IS BEING REPORTED DUE TO THE POTENTIAL FOR HARM IF THE EVENT WERE TO REOCCUR. THEREFORE, THIS REPORT IS BEING FILED AS PART OF AGILENT'S COMMITMENT TO DUE DILIGENCE REPORTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21631617 ↗MalfunctionMar 6, 2025Break; Structural Problem; Break; Structural Problem
THE CHINA CUSTOMER REPORTED " CRACKS HAVE APPEARED IN THE UPPER LEFT AND UPPER RIGHT CORNERS OF THE GLASS DOOR." PICTURE PROVIDED SHOWS THE TOP CORNER OF THE LOWER DOOR DEVELOPED A CRACK CONFIRMING CUSTOMER'S ISSUE. THE FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND REPLACED THE LOWER DOOR. THE INSTRUMENT HAS BEEN REPAIRED, IT IS FULLY OPERATIONAL AND IS AVAILABLE TO THE USER. THE CUSTOMER WAS ABLE TO COMPLETE STAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21540193 ↗MalfunctionMar 5, 2025Mechanical Problem; Device Fell; Mechanical Problem; Device Fell
THE SPAIN CUSTOMER REPORTED " INFERIOR DOOR SPRING DOES NOT WORK NORMALLY" FOR THE COVERSTAINER INSTRUMENT. THE PROBLEM WAS DESCRIBED AS THE DOOR CLOSES SUDDENLY AND THE SHOCK ABSORBERS ARE NOT WORKING CORRECTLY. IT WAS CONFIRMED THAT NO HARM HAS OCCURRED. THE AGILENT FIELD SERVICE ENGINEER (FSE) WENT BACK TO THE CUSTOMER'S SITE AND REPLACED THE SHOCK ABSORBERS. THE INSTRUMENT IS FULLY OPERATIONAL AND READY FOR USE. TESTING WAS ABLE TO BE COMPLETED. WHILE THERE WAS NO DIRECT, OR INDIRECT, USER HARM REPORTED FOR THIS EVENT; IT IS BEING REPORTED DUE TO THE POTENTIAL FOR HARM IF THE EVENT WERE TO REOCCUR. THEREFORE, THIS REPORT IS BEING FILED AS PART OF AGILENT'S COMMITMENT TO DUE DILIGENCE REPORTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21528515 ↗MalfunctionFeb 26, 2025Break; Structural Problem; Break; Structural Problem
THE CUSTOMER IN FRANCE INFORMED THE AGILENT FIELD SERVICE ENGINEER THAT THE LOWER DOOR OF THE COVERSTAINER IS BROKEN. THE PROVIDED PICTURE SHOWS THAT THE TOP CORNER OF THE DOOR IS BROKEN AND HAS DETACHED FROM THE REST OF THE DOOR. FSE SERVICED THE INSTRUMENT AND REPLACED THE LOWER DOOR, SHOCK ABSORBERS AND HINGE. THE INSTRUMENT IS FULLY OPERATIONAL AND READY FOR USE. THE CUSTOMER WAS ABLE TO COMPLETE STAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21469308 ↗MalfunctionFeb 25, 2025Break; Structural Problem; Break; Structural Problem
THE CHINA CUSTOMER REPORTED "LOWER DOOR DAMAGED." A PICTURE PROVIDED SHOWS THE TOP CORNER OF THE DOOR HAS DEVELOPED A CRACK. THE FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND REPLACED THE LOWER DOOR. THE INSTRUMENT HAS BEEN REPAIRED, IT IS FULLY OPERATIONAL AND IS AVAILABLE TO THE USER. THE CUSTOMER WAS ABLE TO COMPLETE STAINING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21458098 ↗
Other Slide stainer, automated devices
- Autostainer Link 48 AS480Agilent Technologies Singapore Pte Ltd · Slide stainer, automated1 recall723 reports
- Artisan Link Pro AR310Agilent Technologies Singapore Pte Ltd · Slide stainer, automated90 reports
- VENTANA HE 600 System 06917259001Ventana Medical Systems, Inc. · Slide stainer, automated1 recall3 reports
- BenchMark ULTRA 110vVentana Medical Systems, Inc. · SLIDE STAINER, AUTOMATED37 reports
- Dako Omnis GI100Agilent Technologies Singapore Pte Ltd · Slide stainer, automated22 reports
- PREVI® COLOR GRAM V2 414292Biomerieux SA · Slide stainer, automated20 reports
- UniCel DxH SMSBeckman Coulter, Inc. · Slide Stainer, Automated5 reports
- BOND-III processing moduleLeica Biosystems Melbourne Pty Ltd · Slide Stainer, Automated5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page