HORIBA custom configured fluorescence instrument — Class II medical device recall Z-2166-2024
Ongoing recall by Horiba Instruments Incorporated, reported 2024-07-10, distributed nationwide. HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configuration of the m
| Recall number | Z-2166-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Horiba Instruments Incorporated, Piscataway, NJ, United States |
| Recall initiated | 2024-03-28 |
| Classified | 2024-07-01 |
| Reported by FDA | 2024-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2166-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.