Z-2166-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2024
- Initiation Date
- March 28, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 4 units
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.
Distribution Pattern
US Nationwide and Worldwide Distribution
Code Information
Modular Fluorolog-QM