BEUDAMED
    FDA Enforcement Class II Terminated

    Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-5390 Hematology Analyzer.

    Recall: Z-1321-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1321-2018
    Event ID
    79556
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 18, 2018
    Initiation Date
    January 24, 2018
    Classification Date
    April 9, 2018
    Termination Date
    April 19, 2019
    Address
    800 Macarthur Blvd, Mahwah, NJ, 07430-2001, United States

    Description

    Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-5390 Hematology Analyzer.

    Reason

    Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzer may cause the system to produce an elevated platelet background count.

    Code Info

    Lot Numbers: 2017060105 ¿ 2017041106 ¿ 2017010701 ¿ 2016121401 ¿ 2016112301 ¿ 2016111302

    Distribution

    US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .

    Quantity

    496