HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
FDA Recall Z-2166-2024 · Posted 2024-07-01
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Recalling FirmHoriba Instruments Incorporated
Recall StatusOpen, Classified
Product CodeREM
Date Initiated2024-03-28
Product Quantity4 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.
Firm Action
Horiba plans to issue an IMPORTANT ELECTRONIC PRODUCT RADIATION WARNING letter to notify affected customers. The notification will Identify the affected product involved, description of the defect, safety hazard imposed: and corrective actions, For questions, call (732) 623-8146.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
US Nationwide and Worldwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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