BOND-MAX Processing ModuleRecalls & reported problems
Leica Biosystems Melbourne Pty Ltd · The BOND system automates clinical protocols for immunostaining of pathology specimens mounted on microscope slides. Microscope slides subsequently undergo interpretation by a qualified healthcare professional to aid diagnosis. · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09349458000011), received between Sep 3, 2024 and Sep 3, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 14 AUGUST 2024, THE COMPLAINANT SUBMITTED A MEDICAL DEVICE ADVERSE EVENT REPORT FOR MARKETING AUTHORIZATION HOLDERS TO THE (B)(6) DOCUMENTING THE FOLLOWING: ¿ABNORMALITIES OCCUR FREQUENTLY, ERRORS ARE REPORTED ALL THE TIME, AND A LARGE NUMBER OF SAMPLES AND FILMS ARE WASTED.¿ ON (B)(6) 2024, LEICA BIOSYSTEMS MELBOURNE RECEIVED THE FOLLOWING INFORMATION: ¿WE RECEIVE AN AE FROM (B)(6) HOSPITAL IN THE (B)(6) ¿PRODUCT NAME:FULLY AUTOMATED IHC AND ISH STAINING SYSTEM PRODUCT CODE/MODEL : BOND-MAX SERIAL NUMBER : (B)(6) DATE OF USE:2024-7-31 AE NUMBER:[REPORT NUMBER] CASE DESCRIPTION:ON (B)(6) 2024, MULFUNCTION [SIC] HAPPENED FREQUENTLY, REPORTED ERRORS, AND WASTED A LOT OF SAMPLES AND FILMS. THE ISSUE LED TO TISSUE DAMAGE. THE CAUSE OF THE ISSUE IS WAITING INVESTIGATION. AFTER REPAIRING, THE INSTRUMENT RETURNED TO NORMAL.¿ ON (B)(6) 2024, THE ASSIGNED CUSTOMER SERVICE ENGINEER CONFIRMED WITH THE CUSTOMER THAT ¿¿SOME PATIENTS HAD REPEATED BIOPSIES. THE DEPARTMENT IS MANAGED BY A TRUSTEE. IF THERE IS A PROBLEM WITH THE EQUIPMENT IN THE DEPARTMENT, THE EQUIPMENT DEPARTMENT WILL CONTACT A THIRD PARTY FOR REPAIR. THE CUSTOMER IS UNWILLING TO PROVIDE DETAILED INFORMATION. WE ALSO ENCOUNTER
Patient problems: Insufficient Information
MAUDE report 20131858 ↗
Other Slide Stainer, Automated devices
- Autostainer Link 48 AS480Agilent Technologies Singapore Pte Ltd · Slide stainer, automated1 recall723 reports
- Dako CoverStainer CS100Agilent Technologies Singapore Pte Ltd · Slide stainer, automated135 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
- BOND-III processing moduleLeica Biosystems Melbourne Pty Ltd · Slide Stainer, Automated5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.