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HORIBA INSTRUMENTS INCORPORATED

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Minocal	1x2.5mL	FDA UDI	Class II	Active
Minotrol Crp	2x2.5mL High	FDA UDI	Class II	Active
Difftrol	24x3 mL	FDA UDI	Class II	Active
Minotrol 16	12x2.5mL	FDA UDI	Class II	Active
Difftrol	12x3 mL	FDA UDI	Class II	Active
Difftrol	3x3 mL	FDA UDI	Class II	Active
Minotrol 16	6x2.5mL	FDA UDI	Class II	Active
Minotrol Retic	12x3mL	FDA UDI	Class II	Active
Minocal	2x2.5mL	FDA UDI	Class II	Active
Minotrol 16	3x2.5mL	FDA UDI	Class II	Active
Minotrol Retic	3x3mL	FDA UDI	Class II	Active
Minotrol Crp	2x2.5mL Low	FDA UDI	Class II	Active
Minotrol Crp	2x2.5mL Normal	FDA UDI	Class II	Active
Difftrol	6x3 mL	FDA UDI	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 28, 2024	Z-2166-2024	—	open, classified	HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configuration of the modular Instrument removed the primary light source and the excitation monochromator. A plastic cap was installed to plug the optical port, where a more durable beam stop should have been used. The defect may allow the class 4 laser beam to burn (or transmit) through the plastic cap to exit the protective enclosure.
Oct 30, 2018	Z-0119-2020	—	terminated	Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase concentration could be observed and a patient result could be declared abnormal by the instrument due to these interferences instead of normal result < 38 U/L (or < reference value used in your laboratory).