Autostainer Link 48 AS480Recalls & reported problems

Summary

The FDA's MAUDE database contains 723 adverse event reports that list this exact device (DI 05700572035497), received between Jul 16, 2020 and Feb 26, 2025 — classified as 723 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (343 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 5, 2019Terminated

   The Autostainer instrument may not have a syringe tray installed which could result in a small volume of excess buffer being applied to several slides. In addition to the syringe tray, the updated Basic User Guide will reduce the potential risk of false negative results in the case of leakage of buffer and/or reagents that may impact staining.

   Z-2074-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 723 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2025Fire; Smoking; Fire; Smoking

  THE UNITED STATES CUSTOMER INFORMED AGILENT APPLICATION SPECIALIST THAT "A PIECE OF EQUIPMENT CAUGHT FIRE." FOLLOWING UP WITH THE CUSTOMER, IT WAS NOTED THE CUSTOMER SMELLED FIRE, BUT DID NOT SEE IT. THE SPRINKLER SYSTEM ACTIVATED, AND EMERGENCY SERVICES RESPONDED TO THE SCENE CONFIRMING THE SPRINKLER SYSTEM HAS EXTINGUISHED THE FIRE. AGILENT FIELD SERVICE ENGINEER (FSE), PROVIDED PICTURES THAT INDICATE MULTIPLE INSTRUMENTS, AND LABORATORY EQUIPMENT, WERE DAMAGED BY THE FIRE, WATER, AND SMOKE. FOLLOWING THE FIRE MARSHAL'S INVESTIGATION A REPORT, NFIRS-2, WAS PROVIDED AT AGILENT'S REQUEST. THE REPORT INDICATES THAT WHILE THE ROOT CAUSE OF IGNITION, AND FACTORS CONTRIBUTING TO IGNITION, ARE UNKNOWN; THE WORKSTATION COMPUTER MONITOR, ATTACHED TO THE AUTOSTAINER INSTRUMENT, WAS DETERMINED TO BE "INVOLVED IN IGNITION." IT WAS CONFIRMED THERE ARE NO INJURIES REPORTED AS A RESULT OF THE FIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21473148 ↗
• MalfunctionJun 1, 2023Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CHINA CUSTOMER REPORTED "SOME SLIDES WERE SHOWING WEAK STAINING". FSE (FIELD SERVICE ENGINEER) INSPECTED THE INSTRUMENT AND FOUND LIQUID DRIPPING FROM THE PROBE. FSE REPLACED ASPIRATION AND DISPENSE CHECK VALVE WHICH RESOLVED THIS MALFUNCTION. THE CUSTOMER WAS ABLE TO COMPLETE STAINING. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR USE. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037576 ↗
• MalfunctionJun 1, 2023Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Obstruction of Flow; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Obstruction of Flow

  THE BRAZIL CUSTOMER REPORTED "RESIDUE ON SOME SLIDES". FSE (FIELD SERVICE ENGINEER) INSPECTED THE INSTRUMENT AND OBSERVED OBSTRUCTION OF THE ASPIRATION AND DISPENSING CHECK VALVE. FSE REPLACED ASPIRATION AND DISPENSE CHECK VALVE WHICH RESOLVED THIS MALFUNCTION. THE CUSTOMER WAS ABLE TO COMPLETE STAINING. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR USE. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037569 ↗
• MalfunctionJun 1, 2023Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE SPAIN CUSTOMER REPORTED "WEAK STAINING ON SOME SLIDES DUE TO REAGENT NOT BEING DISPENSED PROPERLY". FSE (FIELD SERVICE ENGINEER) INSPECTED THE INSTRUMENT AND FOUND ASPIRATION AND DISPENSE CHECK VALVE LEAKING. FSE REPLACED ASPIRATION AND DISPENSE CHECK VALVE WHICH RESOLVED THIS MALFUNCTION. THE CUSTOMER WAS ABLE TO COMPLETE STAINING. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR USE. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037550 ↗
• MalfunctionJun 1, 2023Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CHINA CUSTOMER REPORTED STAINING ISSUES TO SOME SLIDES DUE TO THE PROBE LEAKING. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE ASPIRATION AND DISPENSE CHECK VALVE WHICH RESOLVED THIS MALFUNCTION. THE CUSTOMER WAS ABLE TO COMPLETE STAINING. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR USE. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037516 ↗
• MalfunctionJun 1, 2023Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  CHINA FIELD SERVICE ENGINEER (FSE) REPORTED AN ASPIRATION AND DISPENSE TEST FAILURE DURING MAINTENANCE WITH SOME SLIDES BEING AFFECTED. THE FSE INSPECTED THE INSTRUMENT AND REPLACED THE ASPIRATION AND DISPENSE CHECK VALVE WHICH RESOLVED THIS MALFUNCTION. THE CUSTOMER WOULD USE ANOTHER INSTRUMENT TO FINISH THE TESTING. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR THE USER. DIAGNOSTICS WERE NOT ALTERED. NO HARM OR PATIENT IMPACT WAS INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036794 ↗
• MalfunctionJun 1, 2023Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CHINA CUSTOMER REPORTED THAT WHEN WASHING THE NEEDLE, THE LIQUID COMES OUT OF THE NEEDLE DIAGONALLY WITH SOME SLIDES BEING AFFECTED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND REPLACED THE PROBE WHICH RESOLVED THIS MALFUNCTION. THE CUSTOMER HAS RECUT AND RETESTED THE SLIDES ON ANOTHER INSTRUMENT. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR THE USER. DIAGNOSTICS WERE NOT ALTERED. NO HARM OR PATIENT IMPACT WAS INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036767 ↗
• MalfunctionJun 1, 2023Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  CANADA CUSTOMER REPORTED THAT CELL LINE CONTROLS STAINED INCORRECTLY. PATIENT SLIDES STAINED APPROPRIATELY. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND REPLACED THE ASPIRATION AND DISPENSE CHECK VALVE WHICH RESOLVED THIS MALFUNCTION. THE CUSTOMER IS REPEATING THE TEST ON A DIFFERENT AUTOSTAINER. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR THE USER. DIAGNOSTICS WERE NOT ALTERED. NO HARM OR PATIENT IMPACT WAS INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036761 ↗
• MalfunctionMay 31, 2023Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  THE CHINA CUSTOMER REPORTED LIQUID DRIPPED OUT FROM THE PROBE DURING THE RUN. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE ASPIRATION AND DISPENSE CHECK VALVE WHICH RESOLVED THIS MALFUNCTION. THE CUSTOMER WAS ABLE TO COMPLETE STAINING. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR USE. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17030835 ↗
• MalfunctionMay 31, 2023Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Air/Gas in Device; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Air/Gas in Device

  THE FRANCE CUSTOMER REPORTED THERE WERE STAINING ISSUES DUE TO AIR BUBBLES THAT COULD BE SEEN AT THE STOPCOCK AND WHILE BEING DISPENSED ONTO SOME SLIDES. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE ASPIRATION AND DISPENSE CHECK VALVE. THE CUSTOMER WAS ABLE TO COMPLETE STAINING WITH ANOTHER INSTRUMENT. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17030822 ↗
• MalfunctionMay 25, 2023Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CHINA CUSTOMER REPORTED THE PROBE IS LEAKING AND SOME SLIDES STAIN WEAK. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE ASPIRATION AND DISPENSE CHECK VALVE WHICH RESOLVED THIS MALFUNCTION. THE CUSTOMER WAS ABLE TO COMPLETE STAINING WITH ANOTHER INSTRUMENT. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR USE. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004403 ↗
• MalfunctionMay 25, 2023Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CHINA CUSTOMER REPORTED UNEVEN STAINING WITH SOME OF THE SLIDES. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE ASPIRATION AND DISPENSE CHECK VALVE WHICH RESOLVED THIS MALFUNCTION. THE CUSTOMER WAS ABLE TO COMPLETE STAINING WITH ANOTHER INSTRUMENT. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR USE. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004397 ↗
• MalfunctionMay 25, 2023Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CHINA CUSTOMER REPORTED HEMATOXYLIN STAINING IS INCOMPLETE WITH SOME SLIDES AFFECTED. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE ASPIRATION AND DISPENSE CHECK VALVE AND THE LIQUID SENSOR BOARD FOR Z-HEAD WHICH RESOLVED THIS MALFUNCTION. THE CUSTOMER WAS ABLE TO COMPLETE STAINING WITH ANOTHER INSTRUMENT. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR USE. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004374 ↗
• MalfunctionMay 23, 2023Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Air/Gas in Device; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Air/Gas in Device

  THE NETHERLANDS CUSTOMER REPORTED STAINING ALTERATION WITH A LOT OF SAMPLES. THE SYSTEM WAS PRIMED AND INITIALLY A LOT OF AIR CAME OF BUT THEN LIQUID CAME OUT. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THE CLOGGED PROBE. THE FSE ALSO FOUND THAT THE LIQUID SENSING WAS NOT ACCURATE, REPLACED THE PROBE KIT AND LIQUID SENSING BOARD TO RESOLVE THE ISSUE. THE SYRINGE AND STOPCOCK WERE ALSO REPLACED AS PRECAUTIONARY MEASURE. THE CUSTOMER HAS OTHER INSTRUMENTS TO WORK WITH. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR THE USER. DIAGNOSTICS WERE NOT ALTERED. NO HARM OR PATIENT IMPACT WAS INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16982296 ↗
• MalfunctionMay 23, 2023Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE FRANCE CUSTOMER REPORTED STAINING ALTERATION ON MOST SLIDES. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT THE LIQUID DETECTION VALUES WERE NOT CONSTANT. THE LIQUID SENSOR BOARD AND THE ASPIRATION AND DISPENSE CHECK VALVE WERE REPLACED WHICH RESOLVED THIS MALFUNCTION. THE CUSTOMER ALREADY REPEATED THEIR SLIDES ON ANOTHER INSTRUMENT. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR THE USER. DIAGNOSTICS WERE NOT ALTERED. NO HARM OR PATIENT IMPACT WAS INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16982281 ↗
• MalfunctionMay 19, 2023Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CHINA CUSTOMER REPORTED THE LAST SLIDE COULDN'T BE STAINED. THIS WAS FOUND AFTER THE RUN WAS COMPLETED. THE FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND NOTED, "WHEN RINSING FROM THE PROBE, THE WATER IS DISPENSED BY THE PROBE AND THE WASH HEAD ALSO DRIPPED". THE FSE REPLACED THE 3-WAY PINCH VALVE AND ASPIRATION AND DISPENSE CHECK VALVE WHICH RESOLVED THIS MALFUNCTION. THE CUSTOMER WAS ABLE TO COMPLETE STAINING MANUALLY. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR USE. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16963315 ↗
• MalfunctionMay 19, 2023Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE UNITED STATES OF AMERICA CUSTOMER REPORTED "PROBE WASHING ISSUE". THE CUSTOMER STATES THAT REAGENT CARRY OVER ON SOME SLIDES. THIS SEEMS TO HAPPEN JUST AFTER THE PROBE RINSES AND APPLIES A DIFFERENT ANTIBODY. THE SLIDES HAD EOSIN ON THEM WHICH SHOWED UP AS RED AND CUSTOMER SUSPECTS THAT THE PROBE IS NOT WASHING CORRECTLY. FSE INSPECTED THE INSTRUMENT AND FOUND PROBE DRIPPING FLUID AND LEAKAGE FROM BACK OF SYRINGE. FSE REPLACED SYRINGE AND ASPIRATION AND DISPENSE CHECK VALVE WHICH RESOLVED THIS MALFUNCTION. DIAGNOSTICS WERE NOT ALTERED. THE TESTING WAS ABLE TO BE COMPLETED. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962186 ↗
• MalfunctionMay 19, 2023Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CHINA CUSTOMER REPORTED "SOME PATIENT SLIDES STAINING WEAK/NONE". IT WAS CONFIRMED THAT PRIMARY ANTIBODY USED IS A NON-AGILENT PRODUCT. UPON INVESTIGATION, FSE FOUND THAT THE INSTRUMENT HAD A LIQUID LEVEL DETECTION ERROR AND CONFIRMED THAT IT IS A HARDWARE PROBLEM. FSE INSPECTED THE INSTRUMENT AND NOTICED LIQUID DRIPPING FROM THE PROBE. FSE REPLACED ASPIRATION AND DISPENSE CHECK VALVE AND CONFIRMED THE INSTRUMENT IS FULLY OPERATIONAL AND AVAILABLE FOR USE. DIAGNOSTICS WERE NOT ALTERED. THE TESTING WAS ABLE TO BE COMPLETED WITH ANOTHER INSTRUMENT. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16960804 ↗
• MalfunctionMay 16, 2023Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  LEAKAGE FROM THE PROBE WAS REPORTED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT, CONFIRMED THAT THE PRESSURE OF THE BUFFER PUMP WAS AS HIGH AS 29 PSI, AND CONFIRMED THAT THE ASPIRATION AND DISPENSE CHECK VALVE HAD ALSO DETERIORATED. THE FSE REPLACED THE BUFFER PUMP KIT AND ASPIRATION AND DISPENSE CHECK VALVE WHICH RESOLVED THIS MALFUNCTION. THERE WERE NO STAINING ISSUES FOUND DURING TESTING, BUT IT WAS NOT POSSIBLE TO CONFIRM WHETHER THE CUSTOMER HAD ANY STAINING ISSUES BEFORE THE PREVENTIVE MAINTENANCE. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR THE USER. DIAGNOSTICS WERE NOT ALTERED. NO HARM OR PATIENT IMPACT WAS INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16938580 ↗
• MalfunctionMay 10, 2023Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  LIGHT STAINING ON SEVERAL RUNS WAS REPORTED. THIS IS AN INTERNAL AGILENT INSTRUMENT, PATIENT TESTING IS NOT INVOLVED AND ONLY USED FOR RESEARCH PURPOSES. THE INSTRUMENT WAS INSPECTED; THERE WAS NO EVIDENCE OF A LEAK AT PROBE BLOCK. THE AIR KNIFE PRESSURE WAS A LITTLE HIGH, ALTHOUGH THE AIR KNIFE WAS CLEAN, AS A PRECAUTIONARY MEASURE, THE AIR KNIFE WAS REPLACED. SYSTEM HAD ISSUES WITH THE LIQUID LEVEL SENSE, THE REQUIRED PARTS WERE REPLACED TO ADDRESS THIS ISSUE. THERE WAS A LEAK FOUND FROM THE REAGENT PROBE TIP. THIS WAS A SMALL LEAK AND ONLY SEEMED TO OCCUR WHEN SYSTEM WAS IDLE. THE ASPIRATION AND DISPENSE CHECK VALVE WAS REPLACED AS A PRECAUTIONARY MEASURE. IT IS NOT KNOWN WHETHER THE ASPIRATION AND DISPENSE CHECK VALVE COULD HAVE CONTRIBUTED TO THE ISSUE. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR THE USER. DIAGNOSTICS WERE NOT ALTERED. NO HARM OR PATIENT IMPACT WAS INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16901152 ↗
• MalfunctionMay 10, 2023Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Air/Gas in Device; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Air/Gas in Device

  THE US CUSTOMER REPORTED INCONSISTENT STAINING ON BOTH QC AND PATIENT TISSUE. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE SYRINGE HAD AIR IN IT WHEN ASPIRATING. THE FSE REPLACED THE SYRINGE AND STOPCOCK WHICH RESOLVED THIS MALFUNCTION. THE SLIDES WERE SUCCESSFULLY REPEATED ON ANOTHER AUTOSTAINER WITH THE SAME REAGENT VIALS. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR THE USER. DIAGNOSTICS WERE NOT ALTERED. NO HARM OR PATIENT IMPACT WAS INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16901151 ↗
• MalfunctionMay 5, 2023Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Air/Gas in Device; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Air/Gas in Device

  THE ITALY CUSTOMER REPORTED THEY ARE HAVING RANDOM PROBLEMS WITH HEMATOXYLIN NOT STAINING ON THE WHOLE SIDE (UPPER PART OF 1 SLIDE NOT STAINED). THE CUSTOMER NOTES IT'S NOT CLEAR IF THE DAB ALSO DID NOT WORK OR WAS JUST NEGATIVE. THE CUSTOMER HAD ANOTHER RUN WITH 1 SLIDE WHICH WAS NOT STAINED AT ALL. WHEN THE CUSTOMER REPEATS THE RUNS EVERYTHING WORKS APPROPRIATELY. THE FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND FOUND AIR BUBBLES IN THE SYRINGE AND NOTED THE INSTRUMENT AND SLIDE RACK ARE LEVEL. THE FSE REMOVED THE AIR BUBBLES FROM THE SYRINGE AND REPLACED THE ASPIRATION AND DISPENSE CHECK VALVE WHICH RESOLVED THIS MALFUNCTION. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR USE. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16878394 ↗
• MalfunctionApr 28, 2023Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE UNITED KINGDOM CUSTOMER REPORTED THAT THEY ARE SOMETIMES NOT SEEING STAINING ON THE CONTROL TISSUE ON THE TOP OF THE SLIDE. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE SYRINGE AND STOPCOCK ASSEMBLY WERE LEAKING. THE FSE REPLACED THE SYRINGE, STOPCOCK AND ASPIRATION AND DISPENSE CHECK VALVE WHICH RESOLVED THIS MALFUNCTION. THE CUSTOMER HAS BEEN ABLE TO EVALUATE THE SLIDES OR DO A SECOND STAINING. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR THE USER. DIAGNOSTICS WERE NOT ALTERED. NO HARM OR PATIENT IMPACT WAS INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16830089 ↗
• MalfunctionApr 27, 2023Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Air/Gas in Device; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Air/Gas in Device

  THE JAPAN CUSTOMER REPORTED 2 SLIDES WERE NOT STAINED DUE TO AIR BUBBLES IN THE SYRINGE. THE FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND FOUND AIR BUBBLES IN THE SYRINGE AND STOPCOCK. THE FSE REPLACED THE SYRINGE AND STOPCOCK WHICH RESOLVED THIS MALFUNCTION. THE FSE EDUCATED THE CUSTOMER TO PRIME THE INSTRUMENT 3 TIMES TO ENSURE AIR WAS OUT OF THE SYSTEM. THE CUSTOMER WAS ABLE TO COMPLETE STAINING BY REPEATING THE SLIDES. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR USE. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16824255 ↗
• MalfunctionApr 24, 2023Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Air/Gas in Device; Fluid/Blood Leak; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Air/Gas in Device

  AN AGILENT TECHNOLOGIES INSTITUTION (DAKO NORTH AMERICA) REPORTED THAT THERE ARE SPORADIC SLIDES THAT SEEM TO HAVE LIGHTER STAINING THAN THE OTHERS AND THAT IT DOES NOT HAPPEN ON EVERY RUN. THE INSTRUMENT HAS BEEN SERVICED TO DETERMINE THE SOURCE OF THE ISSUE. THERE WAS A MINOR AIR BUBBLE IN THE SUPPLY LINE AND BUBBLE WAS PRIMED OUT. THE AIR KNIFE PRESSURE WAS TOO HIGH, AND COMPRESSOR WAS REPLACED. THE PROBE BLOCK FOR THE REAGENT PROBE HAD A SMALL LEAK AND PROBE HAS BEEN REPLACED. DURING TROUBLE SHOOTING THE ON-BOARD INTERNAL BAR CODE READER AND LSB CABLE STOPPED WORKING AND THEY HAVE BEEN REPLACED AS WELL. IT WAS CONFIRMED THAT THE ASPIRATION/ DISPENSE TEST COMPLETED SUCCESSFULLY. NORMALLY THERE WOULD BE NO NEED TO CHANGE THE CHECK VALVE, AS IT DID PASS THE TEST. DUE TO THE ISSUE AS PRECAUTIONARY MEASURE THE 3PSI CHECK VALVE WAS REPLACED. ALL SERVICE TESTS WERE COMPLETED WITHOUT ANY ISSUES OR ERRORS. DIAGNOSTICS WERE NOT ALTERED. THE TESTING WAS ABLE TO BE COMPLETED. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16796639 ↗