FDA Device recall Z-2166-2024
HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
- FDA Device
- Class II
- ongoing
- Published 2024-07-10
On 2024-07-10 the FDA classified a Class II recall of HORIBA custom configured fluorescence instrument, modular Fluorolog-QM by Horiba Instruments, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2166-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-28 |
| Published | 2024-07-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Horiba Instruments |
| Distribution | US |
Product
HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
Reason
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.
Identifiers
| code_info | Modular Fluorolog-QM |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Horiba Instruments
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FDA Device · Class II · 2019-10-16 · Horiba Instruments - ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure…
FDA Device · Class II · 2018-07-04 · Horiba Instruments - 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
FDA Device · Class II · 2018-02-07 · Horiba Instruments - 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
FDA Device · Class II · 2018-02-07 · Horiba Instruments - ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use
FDA Device · Class II · 2016-05-04 · Horiba Instruments
All Horiba Instruments recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2166-2024%22
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