# FDA recall Z-2166-2024

> **Horiba Instruments Incorporated** · Class II · device recall initiated 2024-03-28.

## Product

HORIBA custom configured fluorescence instrument, modular Fluorolog-QM

## Reason for recall

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.

## Distribution

US Nationwide and Worldwide Distribution

## Key facts

- **Recall number:** Z-2166-2024
- **Recalling firm:** Horiba Instruments Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-28
- **Report date:** 2024-07-10

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Piscataway, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2166-2024

## Citation

> AI Analytics. FDA recall Z-2166-2024. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-2166-2024. Source: US FDA. Licensed CC0.

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