CLASS II ONGOING Device recall · Reported 10 Jul 2024 · FDA Enforcement Report
Horiba custom configured fluorescence instrument recalled
Horiba Instruments is recalling Horiba custom configured fluorescence instrument, modular Fluorolog-QM, distributed nationwide in the US. The recall was initiated on 28 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2166-2024
- FDA event ID
- 94839
- Recalling firm
- Horiba Instruments, Piscataway, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Mar 2024
- FDA classified
- 1 Jul 2024
- Reported
- 10 Jul 2024
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 28 Mar 2024 | Recall initiated by company | |
| 1 Jul 2024 | Classified by FDA | +95 days |
| 10 Jul 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
Where it was distributed
US Nationwide and Worldwide Distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Modular Fluorolog-QM
Where was it sold?
US Nationwide and Worldwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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