Dako Omnis GI100Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05700573004904), received between Sep 9, 2020 and Apr 17, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025False Negative Result; False Negative Result

  A CUSTOMER IN THE NETHERLANDS REPORTED THAT ON (B)(6) 2024 THE CUSTOMER RAN A TEST FOR ESTROGEN RECEPTOR (ER) AND PROGESTERONE RECEPTOR (PR) AND THE 2 RESULTS WERE "COMPLETELY NEGATIVE, BOTH THE CONTROLS AND THE PATIENT MATERIAL" WITH ONLY "SOME HEMATOXYLIN STAINING WAS VISIBLE". THE POSITIVE CONTROLS WERE ON THE SAME SLIDE WITH THE PATIENT SAMPLE. ALTHOUGH THE POSITIVE CONTROLS WERE NEGATIVE, THE PATIENT SAMPLE WAS RELEASED AS A NEGATIVE RESULT. THE POSITIVE CONTROLS WERE CONFIRMED AS STAINING POSITIVE FOR ER AND PR BEFORE AND AFTER (B)(6) 2024 AND WERE USED WITHIN THE EXPIRATION TIMEFRAME. AS OF (B)(6) 2025, A LATER SAMPLE OF THE SAME PATIENT WAS TESTED, AND THE RESULTS WERE POSITIVE. THE CUSTOMER THEN RE-STAINED THE ORIGINAL NOVEMBER SAMPLE, AND THE RESULTS WERE NOW POSITIVE, MAKING THE NOVEMBER TEST RESULTS, FALSE NEGATIVE. IT WAS CONFIRMED THE NOVEMBER RESULTS WERE RELEASED TO THE PATIENT, AND THIS IS CURRENTLY UNDER INVESTIGATION AT THE HOSPITAL. ON THE SAME RACK/RUN AS THE NOVEMBER STAINING, 3 OTHER MARKERS WERE SUCCESSFULLY STAINED. SEVERAL SUCCESSFUL STAININGS OF THE SAME ANTIBODY VIALS WERE RUN BEFORE AND AFTER (B)(6) 2024 IN THE SAME MACHINE AND IN 2 OTHER INSTRUMENTS WI

  Patient problems: Insufficient Information

  MAUDE report 21859568 ↗
• MalfunctionApr 8, 2024Break; Sparking; Naturally Worn; Break; Sparking; Naturally Worn

  THE AGILENT FIELD SERVICE ENGINEER (FSE) IN NORWAY REPORTED, DURING AN UNRELATED SERVICE FOR THE OMNIS INSTRUMENT, IT WAS DISCOVERED THE SHEATH INSULATION OF THE ELECTRICAL POWER CABLE COMING FROM THE UNINTERRUPTABLE POWER SUPPLY (UPS) AND THE SHEATH INSULATION OF THE WIRES BENEATH THIS WERE DAMAGED AND EXPOSED PRODUCING SPARKS. NO ONE WAS HARMED, NO MEDICAL ATTENTION WAS NEEDED, AND THERE WAS NO FIRE OR SMOKE AS A RESULT OF THIS ISSUE. THE FSE REPLACED THE POWER CABLE AND MADE SURE IT WAS SECURED IN A POSITION WHERE IT COULD NOT CAUSE A REOCCURRING EVENT; RESOLVING THE 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. THE INVESTIGATION DETERMINED THE POWER CABLE WAS DAMAGED BY A BRACKET OF THE OMNIS THAT IS PART OF THE LIFTING FUNCTION OF THE INSTRUMENT. THIS BRACKET IS PART OF THE TRACK FOR THE LEVELING MECHANISM FOR THE BACK FOOT THAT RUNS THROUGH AND SITS BEHIND THE UPS WHERE THE POWER CABLE IS CONNECTED. THIS BRACKET IS NOT INVOLVED IN MOUNTING OR SECURING THE CABLE; THIS C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19063758 ↗
• MalfunctionDec 20, 2023Product Quality Problem; Protective Measures Problem; Product Quality Problem; Protective Measures Problem

  AGILENT FIELD SERVICE ENGINEER (FSE) STATES THAT HER LEFT HAND WAS GRAZED/SCRAPPED BY THE ROTATING FAN WHICH WAS MISSING GUARDS. THIS INJURY OCCURRED BETWEEN HER THUMB AND INDEX FINGER. THERE WERE 3-4 CUTS (LESS THAN AN INCH LONG) AND THE BLEED WAS STOPPED ONCE A BANDAGE WAS APPLIED. THE ENGINEER CONFIRMED THAT HER INJURY HAS HEALED. INVESTIGATION CONFIRMED THAT THE INSTRUMENT IS A Z-SERIES PRODUCTION AND WAS NOT MANUFACTURED WITH GUARDS ON THE BACK SIDE OF THE BULK FANS. THE INSTRUMENT HAS BEEN SERVICED AND GUARDS WERE PLACED ON THE FANS. THE INSTRUMENT IS FULLY OPERATIONAL AND IS AVAILABLE TO THE USER. THIS IS AN INTERNAL AGILENT INSTRUMENT, NO PATIENT DIAGNOSIS INVOLVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 18369190 ↗
• MalfunctionMar 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOG FILES DID NOT SHOW ANY INSTRUMENT ANOMALIES WHICH COULD HAVE CAUSED THE REPORTED ISSUE. IT HAS NOT BEEN POSSIBLE TO GATHER ANY ADDITIONAL INFORMATION FROM THE CUSTOMER TO SUPPORT FURTHER INVESTIGATION. ROOT CAUSE OF THIS PROBLEM COULD NOT BE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16626140 ↗
• MalfunctionJun 14, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: NEGATIVE STAINING ISSUE. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11992322 ↗
• MalfunctionJun 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: FALSE POSITIVE CONTROL ON ONE SLIDE . NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11932897 ↗
• MalfunctionFeb 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: FALSE NEGATIVE STAINING ON TOP OF SLIDES. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375588 ↗
• MalfunctionFeb 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: FALSE NEGATIVE STAINING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375584 ↗
• MalfunctionFeb 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: OMNIS NON SPECIFIC MAGENTA STAINING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375559 ↗
• MalfunctionFeb 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: FALSE NEGATIVE STAINING AND SENSING ISSUE. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375541 ↗
• MalfunctionFeb 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: CD5 WEAK STAINING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375524 ↗
• MalfunctionFeb 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: INCONSISTENT STAINING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375504 ↗
• MalfunctionFeb 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: FALSE NEGATIVE STAININGS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11276461 ↗
• MalfunctionJan 25, 2021Fire; Fire

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: EXTERNAL UPS FOR WORKSTATION CAUGHT ON FIRE. AN AUTOSTAINER UPS WAS USED WITH AN OMNIS DEVICE. LAB REMOVED POWER FROM THE UPS AND PUT OUT THE SMALL FLAME. THE SITE HAS REPLACED THE UPS WITH A NEW ONE. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11227315 ↗
• MalfunctionJan 22, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: FIVE SLIDES HAD NEGATIVE STAINING IN THREE DIFFERENT RUNS. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11217699 ↗
• MalfunctionNov 5, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: WEAK OR ABSENT STAINING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10796215 ↗
• MalfunctionNov 5, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: STAINING FAILURE. NO DIRECT OR INDIRECT PATIENT HARM, OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10796204 ↗
• MalfunctionNov 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: LACK OF STAINING. NO DIRECT, OR INDIRECT PATIENT HARM, OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10781605 ↗
• MalfunctionOct 23, 2020Smoking; Smoking

  BASED ON A RECENTLY LOGGED COMPLAINT REPORT ON (B)(6) 2020, SMOKE/FUMES WERE REPORTED COMING FROM A UNIVERSAL POWER SUPPLY (UPS FROM POWERVAR) ATTACHED TO A DAKO OMNIS DEVICE WITHIN AN ANATOMICAL PATHOLOGY LABORATORY. THE SMOKE/FUMES TRIGGERED AN "ASTHMA-LIKE ATTACK" FOR ONE EMPLOYEE. IN ADDITION, THREE ADDITIONAL EMPLOYEES NOTED "BREATHING ISSUES" BUT DID NOT SEEK OR REQUIRE MEDICAL ATTENTION. THE EMPLOYEE WITH THE "ASTHMA-LIKE ATTACK" SOUGHT MEDICAL ATTENTION BUT WAS ABLE TO RETURNED TO DUTY (DID NOT REQUIRE ANY ABSENCE FROM JOB). THIS EVENT OCCURRED DURING INSTALLATION OF A DAKO OMNIS, THIS UNIT WAS NOT RUNNING PATIENT SAMPLES, SO NO PATIENT TESTING OR PATIENT HARM OCCURRED. NO SERIOUS HARM TO THE USER HAD OCCURRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10731012 ↗
• MalfunctionSep 15, 2020Therapeutic or Diagnostic Output Failure

  SUMMARY: BASED ON COMPLAINT REPORT OR INVESTIGATED FAILURE MODE, THERE WAS A STAINING ALTERATION. CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: INCONSISTENT STAINING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10538681 ↗
• MalfunctionSep 15, 2020Therapeutic or Diagnostic Output Failure

  SUMMARY: BASED ON COMPLAINT REPORT OR INVESTIGATED FAILURE MODE, THERE WAS AN ALTERATION IN STAINING. CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: WEAK TO NO STAINING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10538554 ↗
• MalfunctionSep 9, 2020Incorrect, Inadequate or Imprecise Result or Readings

  SUMMARY: BASED ON COMPLAINT REPORT OR INVESTIGATED FAILURE MODE, THERE WAS AN ALTERATION IN STAINING. CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: WEAK STAINING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10511584 ↗