BenchMark ULTRA 110vRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 04015630981052), received between Nov 12, 2018 and Sep 23, 2026 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Mechanics Altered

  There was an allegation of a staining run issue with the BenchMark ULTRA system. It was reported that there was a misalignment between the reagent carousel position and what was displayed in the software. The staining appear impacted as they are all a single color with no major staining.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870601 ↗
• MalfunctionApr 20, 2026Failure to Transmit Record; Data Problem

  THERE WAS AN ALLEGATION OF A STAINING ISSUE WITH THE BENCHMARK ULTRA SYSTEM. THE CUSTOMER REPORTS THAT THE PATHOLOGIST ORIGINALLY ORDERED A MART 1 STAIN, THEN DELETED THE MART 1 AND RECREATED IT FOR PRAME. HOWEVER, THE STAIN WAS COMPLETED FOR MART 1. THE LABEL WAS PRINTED AFTER THE ORDER WAS PLACED AT 9:22 AM, AND THE RUN STARTED AT 11:40 AM. THE RUN REPORT SHOWS MART1 AND THE PROTOCOLS WERE VERIFIED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931338 ↗
• MalfunctionMar 25, 2026Unintended Ejection

  THE CUSTOMER REPORTED AN ISSUE WITH THE COVER OF THE BENCHMARK ULTRA SYSTEM. IT WAS REPORTED THAT WHILE OPENING THE INSTRUMENT HOOD, THE LID COUNTERBALANCE ASSEMBLY BECAME DETACHED AND FELL INTO FIVE PIECES. THE LID SUBSEQUENTLY FELL, PINCHING THE OPERATOR'S THUMB.

  Patient problems: Nerve Damage

  MAUDE report 24689993 ↗
• MalfunctionJan 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF DISCREPANT STAINING RESULTS FOR SEVERAL PATIENT SAMPLES TESTED ON DIFFERENT BENCHMARK ULTRA SYSTEMS. THE CUSTOMER IS EXPERIENCING SIGNIFICANT INTER-INSTRUMENT VARIABILITY ACROSS 6 DIFFERENT BENCHMARK ULTRA SYSTEMS. THE SAME CONTROL TISSUE SHOWED DIFFERENT STAINING PATTERNS ON EACH SYSTEM. SOME SYSTEMS PRODUCE UNEXPECTED VARIATIONS IN STAINING INTENSITY (WEAKER VS. STRONGER SIGNAL), WHILE OTHERS EXHIBIT ISSUES WITH HOMOGENEITY (PATCHY OR UNEVEN STAINING) ON THE SAME TISSUE STRUCTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23992709 ↗
• MalfunctionJan 5, 2026Program or Algorithm Execution Problem

  THE INITIAL REPORTER ALLEGED THAT THE REAGENT POSITIONS ON THE CAROUSEL OF THE BENCHMARK ULTRA SYSTEM WERE SHIFTED BY ONE POSITION. SEVERAL STAINING SLIDES WERE AFFECTED BY THE ISSUE; HOWEVER, THE ISSUE WAS DETECTED DURING QUALITY CONTROL REVIEW, AND NO ERRONEOUS RESULTS WERE RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959222 ↗
• MalfunctionJan 5, 2026False Negative Result; Program or Algorithm Execution Problem

  THE INITIAL REPORTER ALLEGED THAT THE REAGENT POSITIONS ON THE CAROUSEL OF THE BENCHMARK ULTRA SYSTEM WERE SHIFTED BY ONE POSITION. SEVERAL STAINING SLIDES WERE AFFECTED BY THE ISSUE; ONE SLIDE WAS STAINED WHITE, LEADING TO A NEGATIVE RESULT AND THE REPEAT STAINING RESULT WAS POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958766 ↗
• MalfunctionDec 18, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  THERE WAS AN ALLEGATION OF DISCREPANT HAZARDOUS LABELING ON THE UMONIUM 38 BOTTLE AND ITS MATERIAL SAFETY DATA SHEET (MSDS) THAT IS USED TO DECONTAMINATE THE BENCHMARK ULTRA INSTRUMENT. IT WAS REPORTED THAT THE BOTTLE IS MARKED ONLY WITH A SYMBOL INDICATING IT IS IRRITATING TO THE SKIN, WHILE THE MSDS INCLUDES ADDITIONAL SYMBOLS FOR CORROSIVE AND ENVIRONMENTALLY HAZARDOUS SUBSTANCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837289 ↗
• MalfunctionJun 26, 2025Mechanics Altered; Program or Algorithm Execution Problem; Mechanics Altered; Program or Algorithm Execution Problem

  ROCHE DIAGNOSTICS RECEIVED AN ALLEGATION THAT THE BENCHMARK ULTRA STAINER MODULE DID NOT PROVIDE AN ERROR TO THE CUSTOMER INDICATING A WRONG REAGENT WAS PRESENT IN A REAGENT CAROUSEL POSITION. THE CUSTOMER NOTICED A MISMATCH BETWEEN THE REAGENTS HE SAW LISTED IN THE SYSTEM SOFTWARE AND THOSE PRESENT ON THE REAGENT CAROUSEL. IN POSITION 20 OF THE CAROUSEL, THE SOFTWARE INDICATED THAT THE HELICOBACTER PYLORI ANTIBODY WAS EMPTY. WHEN THE CUSTOMER TRIED CHANGING THE REAGENT, THEY NOTICED THERE WAS CHROMOGRANIN REAGENT IN POSITION 20. THE CUSTOMER STATED THAT THE SAME THING OCCURRED WHEN THE SOFTWARE INDICATED THAT HEMATOXYLIN IN POSITION 35 WAS EMPTY, BUT IN REALITY, IT WAS IN POSITION 1 OF THE CAROUSEL. IN POSITION 35, THERE WAS "HTX II" REAGENT. THE CUSTOMER STATED THAT IT SEEMED EVERYTHING HAD SLIPPED BY ONE POSITION. THE ERROR LOG OF THE INSTRUMENT WAS RETRIEVED, THE LOG SHOWED AN ERROR INDICATING A CAROUSEL MISALIGNMENT MESSAGE. HOWEVER, NO ERRORS WERE RELAYED TO THE CUSTOMER THROUGH THE SYSTEM SOFTWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335940 ↗
• MalfunctionJun 11, 2025Appropriate Device Problem Term/Code Not Available; Data Problem; Appropriate Device Problem Term/Code Not Available; Data Problem

  THE INITIAL REPORTER COMPLAINED OF AN ISSUE WITH THE PATIENT DATA PRINTED ON LABELS USING VSS SOFTWARE VERSION 12.5.4 WITH A BENCHMARK ULTRA SYSTEM. THE CUSTOMER ALLEGES THAT THE LABELS WITH PATIENT INFORMATION WERE INCORRECT, SPECIFICALLY THE BLOCK NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185144 ↗
• MalfunctionApr 4, 2025Sparking; Sparking

  WE RECEIVED AN ALLEGATION OF AN ISSUE WITH A BENCHMARK ULTRA SYSTEM. THE CUSTOMER ALLEGEDLY HEARD A NOISE SOUNDING LIKE A SHORT CIRCUIT ASSOCIATED WITH THE SUDDEN SHUTDOWN OF THE INSTRUMENT. THE CUSTOMER REPORTEDLY SMELLED A STRONG BURNING ODOR, AND SMOKE WAS COMING FROM THE INSTRUMENT. THE LABORATORY WAS TEMPORARILY EVACUATED AS A PRECAUTION. THE CUSTOMER LEFT THE WINDOWS OPEN AS THE SMELL REMAINED "VERY" STRONG AFTER 3 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774175 ↗
• InjuryMar 6, 2025Use of Device Problem; Use of Device Problem

  THERE WAS AN ALLEGATION OF AN ISSUE WITH THE BENCHMARK ULTRA SYSTEM THAT REPORTEDLY CONTRIBUTED TO A LABORATORY TECHNICIAN¿S EYE INJURY. THE TECHNICIAN WAS ALLEGEDLY EXPOSED TO "STEAM" WHILE LOADING A REAGENT KIT ONTO THE INSTRUMENT DURING A REAGENT ACCESS POINT (RAP). UPON OPENING THE HOOD, "STEAM" REPORTEDLY ESCAPED AND ENTERED THE TECHNICIAN'S EYE, CAUSING A CORNEAL INJURY. THE TECHNICIAN WAS NOT WEARING EYE PROTECTION AT THE TIME OF THE EVENT. THE TECHNICIAN ALLEGEDLY SOUGHT MEDICAL ATTENTION AT AN EYE HOSPITAL WHERE THE EYE WAS REPORTEDLY FLUSHED WITH 3L OF SODIUM CHLORIDE (NACL) AND EYE DROPS WERE USED TO FURTHER EXAMINE THE CORNEA. THE EYE DOCTOR ALLEGEDLY OBSERVED MILD DAMAGE TO THE CORNEA AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR 5 DAYS AS A PRECAUTIONARY MEASURE. THE PATIENT RETURNED TO THE EYE DOCTOR FOR A FOLLOW-UP VISIT. THE CORNEA HAD COMPLETELY HEALED, BUT THE PATIENT WAS REPORTEDLY CONTINUING TO EXPERIENCE SOME DRY EYE SYMPTOMS. THE PATIENT IS REPORTEDLY USING MOISTURIZING EYE DROPS. THE EYE DOCTOR REPORTEDLY EXPECTS THE MILD CORNEAL INJURY TO IMPROVE OVER TIME. THERE IS NO REPORT OF ANY PERMANENT DAMAGE/IMPAIRMENT OF THE EYE.

  Patient problems: Corneal Clouding/Hazing

  MAUDE report 21537144 ↗
• MalfunctionFeb 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Failure to Align; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Align

  THE INITIAL REPORTER ALLEGED THAT THE POSITIONS OF THE REAGENTS ON THE CAROUSEL OF THE BENCHMARK ULTRA SYSTEM AND THOSE IN THE VSS SOFTWARE VERSION 12.5.4 DID NOT MATCH. THE SCANNED REAGENTS ON THE CAROUSEL WERE SHIFTED BY ONE POSITION IN THE SOFTWARE. SEVERAL SLIDES WERE AFFECTED BY THE ISSUE; SOME SLIDES WERE NOT STAINED AT ALL AND OTHER SLIDES WERE NOT STAINED WITH THE CORRECT REAGENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412915 ↗
• MalfunctionJun 26, 2024False Negative Result; Contamination /Decontamination Problem; False Negative Result; Contamination /Decontamination Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH THE PATHWAY ANTI-HER2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY FOR ONE PATIENT TESTED ON A BENCHMARK ULTRA STAINER MODULE. THE ALLEGED SAMPLE INITIALLY GENERATED A NEGATIVE RESULT. THE PHYSICIAN QUESTIONED THE RESULT AND REQUESTED A REPEAT. THE SAMPLE WAS REPEATED ON A COMPETITOR'S DEVICE (LEICA), GENERATING A POSITIVE RESULT USING THE SAME ANTIBODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613469 ↗
• MalfunctionMar 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A CUSTOMER REPORTED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES USING THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL ASSAY ON THE BENCHMARK ULTRA STAINER MODULE. THE ALLEGED SAMPLES WERE INITIALLY STAINED AS NEGATIVE, BUT REPEAT TESTING RETURNED POSITIVE STAINING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18892443 ↗
• MalfunctionJan 12, 2024Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  THE CUSTOMER REPORTED AN ISSUE WITH THE COVER OF THE BENCHMARK ULTRA STAINER MODULE. THE OPERATOR WAS LOADING REAGENTS AND THE COVER REPORTEDLY FELL ONTO THE OPERATOR'S WRIST.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507214 ↗
• InjuryNov 15, 2023Use of Device Problem; Use of Device Problem

  WE RECEIVED INFORMATION THAT AN OPERATOR SUFFERED AN INJURY FROM SLIPPING ON LIQUID THAT HAD LEAKED FROM A WASTE CARBOY OF THE BENCHMARK ULTRA STAINER MODULE.

  Patient problems: Limb Fracture

  MAUDE report 18138985 ↗
• MalfunctionMay 25, 2023Intermittent Program or Algorithm Execution; Intermittent Program or Algorithm Execution

  THE INITIAL REPORTER ALLEGED THAT TWO PATIENT SAMPLE SLIDES WERE STAINED WITH THE WRONG ANTIBODY ON BENCHMARK ULTRA SERIAL NUMBER (B)(6). THE FIRST PATIENT SAMPLE SLIDE WAS ALLEGEDLY LABELED TO BE STAINED WITH THE PMS2 ANTIBODY PROTOCOL, BUT THE SLIDES WERE STAINED AND RUN WITH THE CD117 ANTIBODY. THE SECOND PATIENT SLIDE WAS LABELED WITH THE CD117 ANTIBODY PROTOCOL BUT WAS STAINED WITH THE CD3 PROTOCOL WHEN RUN. THE ISSUE WAS IDENTIFIED AT THE LAB. NO HARM IS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004319 ↗
• MalfunctionMay 12, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM TURKEY ALLEGED INCORRECT (POSITIVE) STAINING ON TWO BONE MARROW SLIDES WHILE USING THE BENCHMARK ULTRA INSTRUMENT, WHICH OCCURRED ON (B)(6) 2023. NON-ROCHE ANTIBODIES CD38, CD34, AND CD117 WERE USED DURING THE STAINING PROCESS. THE CUSTOMER RESTAINED THE SLIDES ON (B)(6) 2023 USING THE SAME ANTIBODIES AND THE SLIDES WERE STAINED APPROPRIATELY (NEGATIVE), AND AS EXPECTED. THE RESULTS OF THE ALLEGED INCORRECT STAINED SLIDES WERE NOT REPORTED. NO HARM IS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919490 ↗
• MalfunctionApr 19, 2023Unable to Obtain Readings; Program or Algorithm Execution Failure; Unable to Obtain Readings; Program or Algorithm Execution Failure

  A CUSTOMER FROM GERMANY ALLEGED A STAINING ISSUE FOR ONE PATIENT USING THE BENCHMARK ULTRA INSTRUMENT. THE CUSTOMER ALLEGED THE INSTRUMENT RAN A DIFFERENT PROTOCOL THAN THE ONE GIVEN ON THE BARCODE LABEL. AN ERROR MESSAGE WAS RECEIVED FROM THE SOFTWARE. A NEW SLIDE FROM THE SAME PATIENT WAS RERUN AND GENERATED THE SAME ISSUE. THE ISSUE WAS CAUGHT BY LAB PERSONNEL AND THERE WAS NO PATIENT IMPACT. NO HARM IS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16767173 ↗
• MalfunctionMar 9, 2023Intermittent Program or Algorithm Execution; Intermittent Program or Algorithm Execution

  A CUSTOMER FROM GERMANY ALLEGED A STAINING ISSUE FOR ONE SLIDE USING THE BENCHMARK ULTRA INSTRUMENT. ONE SLIDE WAS INTENDED FOR PREPKIT#185, HOWEVER, AN ERROR MESSAGE APPEARED REQUESTING ANOTHER ANTIBODY (CD34 (QBEND10) FOR THIS SLIDE. THE ISSUE WAS DISCOVERED AS THE REQUESTED ANTIBODY CD34 (QBEND10) WAS NOT ON THE INSTRUMENT. NO RESULTS WERE GENERATED. NO HARM IS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513201 ↗
• MalfunctionFeb 16, 2023Patient Data Problem; Patient Data Problem

  A CUSTOMER FROM CANADA ALLEGED THAT SEVEN SLIDES (PATIENT ORDERS) APPEAR TO HAVE BEEN STAINED ON THE BENCHMARK ULTRA WITH A DIFFERENT STAINING PROTOCOL THAN WHAT WAS ASSIGNED ON THE SLIDE LABEL (BARCODE) AND INTENDED TO BE USED. THE RESULT WAS REPORTED OUT TO THE TREATING PHYSICIAN FOR ONE OF THESE SEVEN SLIDES, HOWEVER IT WAS CONFIRMED THAT THE PATIENT WAS NOT TREATED BASED ON THE INCORRECTLY STAINED SLIDE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16388801 ↗
• MalfunctionFeb 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM TURKEY ALLEGED INCORRECT STAINING FOR TWO SLIDES USING THE BENCHMARK ULTRA INSTRUMENT, WHICH OCCURRED ON (B)(6) 2023. ONE SLIDE WAS INTENDED FOR CD61 STAINING AND ONE SLIDE WAS INTENDED FOR MPO STAINING. HOWEVER, EACH OF THESE TWO SLIDES WERE STAINED WITH GLYCOPHORIN. THE CUSTOMER RESTAINED THE SLIDES ON 10 JAN 2023 ON THE SAME INSTRUMENT AND BOTH WERE STAINED APPROPRIATELY AND AS EXPECTED. THE RESULTS OF THE ALLEGED INCORRECT STAINED SLIDES WERE NOT REPORTED. NO HARM IS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16351376 ↗
• MalfunctionDec 21, 2022Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  A CUSTOMER FROM CHINA OBSERVED EVIDENCE OF A DAMAGED CURRENT SENSE PRINTED CIRCUIT BOARD (PCB) AND CABLES ON THE BENCHMARK ULTRA INSTRUMENT. NO EVACUATION NEEDED. THE PART SELF-EXTINGUISHED. NO HARM OR INJURY ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16026126 ↗
• MalfunctionDec 15, 2022Degraded; Device Emits Odor; Degraded; Device Emits Odor

  A CUSTOMER FROM JAPAN ALLEGED THAT A BENCHMARK ULTRA DEVICE SUDDENLY SHUT DOWN DURING A RUN AND EMITTED A BURNT ODOR. NO HARM OR INJURY ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992315 ↗
• MalfunctionNov 25, 2022Circuit Failure; Sparking; Circuit Failure; Sparking

  A FIELD SPECIALIST OBSERVED EVIDENCE OF CHARRING/BURNING OF THE CELL BUS PRINTED CIRCUIT BOARD (PCB) ON THE BENCHMARK ULTRA INSTRUMENT FOR A CUSTOMER FROM THE NETHERLANDS. NO HARM OR INJURY ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15866712 ↗