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Horiba Instruments Incorporated Recalls
2 recalls on record · October 16, 2019 to July 10, 2024 · Medical Devices
Recalls by year
19
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
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The recall feeds record what looks like the same company under more than one name:
July 10, 2024Medical DevicesFDA
Horiba Instruments Incorporated recalls HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
Hazard: 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.
October 16, 2019Medical DevicesFDA
Horiba Instruments Incorporated recalls Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03
Hazard: Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase concentration could be observed and a patient result could be declared abnormal by the instrument due to these interferences instead of normal result < 38 U/L (or < reference value used in your laboratory).