BEUDAMED
    FDA Enforcement Class II Terminated

    Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011

    Recall: Z-1001-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-1001-2020
    Event ID
    84614
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Clinical Diagnostic Solutions, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 12, 2020
    Initiation Date
    January 2, 2020
    Classification Date
    February 5, 2020
    Termination Date
    November 3, 2022
    Address
    1800 NW 65th Ave, N/A, Plantation, FL, 33313-4544, United States

    Description

    Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011

    Reason

    A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.

    Code Info

    Part Number 1400075 (US) Part Number 1400011 (OUS) All serial numbers distributed prior to 3/21/2019

    Distribution

    Worldwide distribution. US Nationwide, Venezuela, Africa, Italy, Brazil, and Ukraine. No governmental, Canadian, or Mexican consignees.

    Quantity

    261