FDAFDA · Food and drugs·Recall number Z-2166-2024
HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
Published July 10, 2024 · Recall initiated: March 28, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Horiba Instruments Incorporated
- Distributor
- US Nationwide and Worldwide Distribution
- Lot
- Modular Fluorolog-QM
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.