BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1001-2020 · Initiated January 2, 2020

    Recall

    Recall Number
    Z-1001-2020
    Event Number
    84614
    Firm
    Clinical Diagnostic Solutions, Inc.
    FEI Number
    3002684533
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 2, 2020
    Terminated
    November 3, 2022
    Address
    1800 NW 65th Ave, Plantation, FL, 33313-4544

    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.

    Action

    Consignees notified via email and postal delivery with recall letter dated 01/02/2020. The letter identified affected product, stated reason for recall, and provided specific actions to follow. A Recall Acknowledgement Form was requested to be returned by email, postal delivery, or fax. Clinical Diagnostic Solutions Inc. is handling US consignees only. Boule Medical AB is handling OUS consignees.

    Distribution

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

    Quantity

    261