Medical device recalls Moderate risk

Horiba Instruments Incorporated recalls HORIBA custom configured fluorescence instrument, modular Fluorolog-QM

Recall date
March 28, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2166-2024
FDA classification
Class II
Brand / firm
Horiba Instruments Incorporated
Sold / distributed
US Nationwide and Worldwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HORIBA custom configured fluorescence instrument, modular Fluorolog-QM

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