BEUDAMED
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    REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.

    FDA Recall
    Open, Classified ·Cellavision AB Forskningsbyn Ideon Scheelevagen 19a Lund Sweden·Product code JOY·October 8, 2025

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

    FDA Recall
    Open, Classified ·Sysmex America, Inc.·Product code LXG·December 15, 2025

    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 Recall
    Open, Classified ·Sysmex America, Inc.·Product code PER·January 6, 2025