HORIBA Fluorolog-QM Fluorescence Instrument Laser Safety Defect Recall
HORIBA recalled 4 Fluorolog-QM fluorescence instruments due to a laser safety defect. A plastic cap instead of a proper beam stop may allow a Class 4 laser beam to exit the protective enclosure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall addresses a risk-of-harm product (Class 4 laser exposure capable of causing serious burns) where no illnesses or injuries have yet been reported. The hazard is significant but theoretical, meeting the rubric criterion for High severity.
Plain-English summary
HORIBA Instruments Incorporated has recalled 4 units of the custom-configured Fluorolog-QM fluorescence instrument due to a laser safety defect. The instruments have been distributed nationwide and worldwide.
The recalled instruments were custom configured to remove the primary light source and excitation monochromator. To seal the optical port where these components would normally be located, a plastic cap was installed instead of a more durable beam stop. This creates a potential safety hazard.
The plastic cap is not sufficiently durable to withstand a Class 4 laser beam. The laser may burn through or transmit through the plastic cap and exit the protective enclosure, potentially exposing users or bystanders to high-energy laser radiation capable of causing eye and skin burns.
The recalled product
- Product
- HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
- Manufacturer
- Horiba Instruments Incorporated
- Category
- Medical Device
- Hazard
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Modular Fluorolog-QM
Distribution
Distributed nationwide across the United States.
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