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BOND-MAX Processing Module

LEICA BIOSYSTEMS MELBOURNE PTY LTD · Model BOND-MAX · UDI-DI 09349458005689

KPA Prescription

510(k) clearances

1,446

Adverse events (1 deaths)

Recalls

Facilities

Description

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.

Recalls

Date	Firm	Reason
2024-04-02	Agilent Technologies	There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.
2022-06-01	Ventana Medical Systems Inc	There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
2022-01-20	Ventana Medical Systems Inc	Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke
2021-04-16	Hardy Diagnostics	Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.
2021-02-25	Biocare Medical, LLC	Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could re
2020-08-31	Roche Diagnostics Operations, Inc.	Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the elect
2020-08-31	Roche Diagnostics Operations, Inc.	Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the elect
2019-11-05	Dako Denmark A/S	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 t
2019-10-04	Ventana Medical Systems Inc	The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic patholo
2018-09-17	Leica Microsystems, Inc.	The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard because it could contain an improperly-mixed phosphorus compound.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.