BEUDAMED
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    TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17

    FDA Enforcement
    Class II ·Ongoing·Sysmex America, Inc.·January 28, 2026

    Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.

    FDA Enforcement
    Class II ·Ongoing·Sysmex America, Inc.·February 12, 2025