Z-2166-2024Class II

HORIBA custom configured fluorescence instrument, modular Fluorolog-QM

Name: Z-2166-2024 HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
Creator: Horiba Instruments Incorporated
Published: 2024-03-28
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2024-03-28 / Open, Classified

FDA source

Horiba Instruments Incorporated began a recall of HORIBA custom configured fluorescence instrument, modular Fluorolog-QM on 2024-03-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2166-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-28
Posted: 2024-07-01
Recalling firm: Horiba Instruments Incorporated
Product: HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
Product code: REM Spectroscopy Instrument
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.
FDA root cause: Radiation Control for Health and Safety Act
Action: Horiba plans to issue an IMPORTANT ELECTRONIC PRODUCT RADIATION WARNING letter to notify affected customers. The notification will Identify the affected product involved, description of the defect, safety hazard imposed: and corrective actions, For questions, call (732) 623-8146.
Quantity in commerce: 4 units
Distribution: US Nationwide and Worldwide Distribution
Product codes and lots: Modular Fluorolog-QM

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2166-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2166-2024	Class II	Ongoing	FDA Mandated	2024-07-10	2024-07-01

Product code REM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)