HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
Summary
The FDA issued a Class II for HORIBA custom configured fluorescence instrument, modular Fluorolog-QM by Horiba Instruments Incorporated. Reason: HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configuration of the modular Instrument removed the primary l.
Details
Source
Device Recall
External ID
Z-2166-2024
Action Date
2024-07-10
Status
Ongoing
Category
device
Product Description
HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
Lot/Code Info: Modular Fluorolog-QM
Quantity Affected: 4 units
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
US Nationwide and Worldwide Distribution
Type: FDA Mandated
Recall Initiated: 2024-03-28
Company
Piscataway, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Horiba Instruments Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Horiba Instruments Incorporated have FDA actions?
This is the only FDA action we have on record for Horiba Instruments Incorporated in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2166-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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