BEUDAMED
    FDA Enforcement Class II Terminated

    Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.

    Recall: Z-2687-2020 · Reported July 29, 2020

    Enforcement

    Recall Number
    Z-2687-2020
    Event ID
    85959
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sysmex America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2020
    Initiation Date
    July 6, 2020
    Classification Date
    July 22, 2020
    Termination Date
    May 21, 2021
    Address
    577 Aptakisic Rd, N/A, Lincolnshire, IL, 60069-4325, United States

    Description

    Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.

    Reason

    Insufficient amount of antibody without an error message or alarm

    Code Info

    Serial Numbers: 1906007896 1907014703 1908002274 1908002273 1907014704 1903011967 1903011968 1903011966

    Distribution

    US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.

    Quantity

    8 units