Recall Z-2166-2024— Horiba Instruments Incorporated
Class II · Ongoing
Class II FDA medical device recall by Horiba Instruments Incorporated, initiated 2024-03-28. FDA's recall record names no specific 510(k) clearance for this event. Product: HORIBA custom configured fluorescence instrument, modular Fluorolog-QM. Reason: 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..
- Recalling firm
- Horiba Instruments Incorporated
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-28
- Firm location
- Piscataway, NJ, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.