BEUDAMED
    3 results · 26ms · Sources: EU EUDAMED, US FDA

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    UNKNOWN

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 20, 2019

    The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines.

    FDA Enforcement
    Class II ·Terminated·Sysmex America, Inc.·April 22, 2020

    The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines.

    FDA Recall
    Terminated ·Sysmex America, Inc.·Product code LXG·March 9, 2020