BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-1703-2020 · Reported April 22, 2020

    Enforcement

    Recall Number
    Z-1703-2020
    Event ID
    85254
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sysmex America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 22, 2020
    Initiation Date
    March 9, 2020
    Classification Date
    April 14, 2020
    Termination Date
    March 24, 2021
    Address
    577 Aptakisic Rd, Lincolnshire, IL, 60069-4325, United States

    Description

    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.

    Reason

    Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error condition occurs requiring the operator to open the cover door of the CF-70 to remove slides or slide magazines from the CF-70, the operation of the CF-70 does not halt.

    Code Info

    Catalog No. AH699752.

    Distribution

    USA nationwide distribution in the states of AK, AR, AZ, CA, CO, CT, DE, FL, IL, KY, LA, MA, MD, MI, MO, MS, MT, NC, NJ, NM, NY, OH, OK, OR, PA, TN, TZ, UT and WA..

    Quantity

    93 units.