BOND-III processing moduleRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 09349458000004), received between Oct 5, 2023 and May 22, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 07 MAY 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: ¿BOND-III, THERE ARE SCRATCHES ON THE DETECTION TISSUE AFTER THE INSTRUMENT GETS OFF THE PLANE, AND PART OF THE TISSUE IS LOST.¿ ON 09 MAY 2025, THE ASSIGNED LEICA FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND DOCUMENTED THE FOLLOWING INFORMATION: ¿ACCORDING TO THE CUSTOMER'S DESCRIPTION, THE OCCURRENCE OF TISSUE SCRATCHES IS OCCASIONAL. ON-SITE INSPECTION REVEALED THAT THE PROBE, COVERTILE, SLIDE RACK, AND SSA WERE ALL NORMAL, AND NO ISSUES WERE FOUND WITH THE INSTRUMENT'S HARDWARE. ONLY IN THE DEWAXING SOLUTION REAGENT BOTTLE WERE SOME INCOMPATIBLE LIQUIDS FOUND, AND IN THE ALCOHOL REAGENT BOTTLE, SOME BLACK PARTICLE PRECIPITATES WERE DISCOVERED. CLEAN THE REAGENT BOTTLES AND REPLACE THE CONTAMINATED REAGENTS. TEST OK.¿ ON 10 MAY 2025, THE ASSIGNED LEICA FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND DOCUMENTED THE FOLLOWING INFORMATION: ¿CLEANED DEWAX AND ALCOHOL BOTTLES AND REPLACED THE REAGENTS. THERE WERE NO SAME PROBLEM HAPPENING IN TWO DAYS, OBSERVING FOR A WHILE.¿ ON 14 MAY 2025, LEICA BIOSYSTEMS MELBOURNE RECEIVED INFORMATION FROM THE LOCAL LEICA QA SPECIALIST, QARA THAT ¿¿THIS C

  Patient problems: Insufficient Information

  MAUDE report 22075475 ↗
• MalfunctionJun 13, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2024, THE COMPLAINANT CONTACTED LEICA BIOSYSTEMS WITH THE FOLLOWING DETAILS: ¿ERROR 126 AND COVERTILE ISSUE ERROR 126 ASPIRATION PROBE RECOVERED COVERTILE ARE MISALIGNED DURING RUN. FAS [NAME] IS AWARE OF THE CLIPPED CORNERS, AND IS REQUESTING SERVICE FOR ERROR 126¿. ON (B)(6) 2024, A LOCAL LEICA TECHNICAL SUPPORT ENGINEER DOCUMENTED: ¿...CUSTOMER IS USING CLIPPED CORNER SLIDES, ( A LIKELY CAUSE OF THE COVERTILE ISSUE )...¿ ON (B)(6) 2024, THE ASSIGNED LEICA FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND RECORDED THE FOLLOWING INFORMATION: ¿THE CUSTOMER COMPLAINED OF RECIEVING [SIC] ERROR 126 SOFTWARE ERROR, XYZ_ERROR: ACTION_RUN_ERROR_XYZ_MOVE_FAIL. ERROR CODE 116 OCCURRED ONCE DURING THE RUN EVENTS. CHECKED ALL CALIBRATION, CONDUCTED EXTREMITY TEST , CHECKED Z AXIS HOME FLAG AND IT WAS NOT BENT. CHECKED Z AXIS INSULATOR BLOCK BRACKET AND LOOM WERE NOT FOULING ON THE ROBOT ARM. X AXIS BELT AND ALL CONNECTIONS WERE SECURE.¿ THE FSE ¿VERIFIED CALIBRATION ADVISED CUSTOMER TO MARK SLIDE TRAYS TO BETTER IDENTIFY POSSIBLE PROBLEMATIC TRAYS. CUSTOMER AT THIS TIME HAS 4 GEN 1 SLIDE TRAYS AND 1 GEN 3 TRAYS. CONDUCTED CALIBRATION VERIFICATION USING GEN 3 SLIDE TRAY WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534399 ↗
• InjuryOct 27, 2023Off-Label Use; Off-Label Use

  ON (B)(6) 2023, LEICA BIOSYSTEMS MELBOURNE RECEIVED THE FOLLOWING INFORMATION FROM THE LOCAL LEICA SENIOR APPLICATION CONSULTANT: "1 PATIENT: PROBABLE HARM, DID NOT HAVE NEOADJ [SIC] CHEMO, STOPPED HORMONAL THERAPY, 5 PATIENTS: DOUBT ABOUT CLINICAL CONSEQUENCE (PARTIAL TTT RESPONSES TO NEOADJ [SIC] CHEMO OR NO NEOADJ [SIC] CHEMO), 2 PATIENTS: HORMONAL THERAPY DISCONTINUATION". AN IDENTIFIER, AGE OR DATE OF BIRTH AND GENDER FOR THE EIGHT (8) PATIENT CASES FOR WHICH THERE IS "POSSIBLE HARM." HAS NOT BEEN PROVIDED TO LEICA BIOSYSTEMS.

  Patient problems: Insufficient Information

  MAUDE report 18018060 ↗
• InjuryOct 27, 2023Off-Label Use; Off-Label Use

  ON 05 DECEMBER 2023, LEICA BIOSYSTEMS MELBOURNE RECEIVED THE FOLLOWING INFORMATION FROM THE LOCAL LEICA SENIOR APPLICATION CONSULTANT: "1 PATIENT: PROBABLE HARM, DID NOT HAVE NEOADJ [SIC] CHEMO, STOPPED HORMONAL THERAPY, 5 PATIENTS: DOUBT ABOUT CLINICAL CONSEQUENCE (PARTIAL TTT RESPONSES TO NEOADJ [SIC] CHEMO OR NO NEOADJ [SIC] CHEMO), 2 PATIENTS: HORMONAL THERAPY DISCONTINUATION". AN IDENTIFIER, AGE OR DATE OF BIRTH AND GENDER FOR THE EIGHT (8) PATIENT CASES FOR WHICH THERE IS "...POSSIBLE HARM." HAS NOT BEEN PROVIDED TO LEICA BIOSYSTEMS.

  Patient problems: Insufficient Information

  MAUDE report 18018058 ↗
• MalfunctionOct 5, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2023, THE COMPLAINANT CONTACTED LEICA BIOSYSTEMS AND THE FOLLOWING DETAILS WERE DOCUMENTED: "FAS [NAME] CALLED IN THE ISSUE. MAIN ROBOT CRITICAL ERR, RUN ABANDONED ON SSA 2 ABLE TO REPEAT SLIDES. HESITANT TO USE THE OTHER SSA AND NO REPORTED ISSUE ON THE OTHER TRAYS". ON (B)(6) 2023, THE ASSIGNED LOCAL LEICA FIELD APPLICATIONS SPECIALIST IMMUNOHISTOCHEMISTRY (FAS) VISITED THE CUSTOMER SITE AND RECORDED THE FOLLOWING INFORMATION: "CUSTOMER REPORTED STAINING ISSUES ON RECENT BOND III PROCESSING MODULE AND REQUESTED ASSISTANCE". THE FAS NOTED "THE PROCESSING MODULE IS WELL-MAINTAINED, PH APPROPRIATE BULK FLUIDS, AND SYRINGE PRIMES APPROPRIATELY...PULLED RUN EVENTS FOR THE AFFECTED SLIDES AND FOUND THAT A MAIN ROBOT CRITICAL ERROR HAD OCCURRED, AND THE RUN WAS ABANDONED. REQUESTED AN FSE ON SITE TO FURTHER EVALUATE THE ISSUE." THE LEICA FAS ALSO CONFIRMED THAT THERE WAS NO IMPACT TO PATIENT DIAGNOSIS DUE TO THIS EVENT. THE FAS FURTHER NOTED "CUSTOMER STATES THAT 9 SLIDES DID NOT STAIN/INCONSISTENT STAINING AND SOMEHOW COVERTILES ARE NOT PLACED BACK ON THE SLIDES DURING PROCESSING." THE FAS DOCUMENTED THE AFFECTED PATIENT SLIDES WERE DERIVED FROM ONE (1) "[NAME] DAB" TISSUE ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17883021 ↗