BEUDAMED
    FDA Enforcement Class II Terminated

    AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagents and software package: AQUIOS Tetra-1 Panel monoclonal antibody reagents, AQUIOS Tetra-2+ Panel monoclonal antibody reagents, and AQUIOS CL Flow Cytometry Software.

    Recall: Z-0091-2018 · Reported November 22, 2017

    Enforcement

    Recall Number
    Z-0091-2018
    Event ID
    78256
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 22, 2017
    Initiation Date
    October 2, 2017
    Classification Date
    November 15, 2017
    Termination Date
    May 8, 2019
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagents and software package: AQUIOS Tetra-1 Panel monoclonal antibody reagents, AQUIOS Tetra-2+ Panel monoclonal antibody reagents, and AQUIOS CL Flow Cytometry Software.

    Reason

    The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)

    Code Info

    All existing software versions (2.0, 2.0.1, and 2.1).

    Distribution

    Worldwide Distribution - US Distribution to the states of : AZ, CA, CO, FL, GA, IL, IN, KS, NC, NY, OR, PA, SC, TX, and WA, including Puerto Rico and government distribution, and to the countries of : Canada, Angola, Australia, Belgium, Botswana, Brazil, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Kenya, Lesotho, Malawi, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, Ukraine, United Kingdom, and Zambia.

    Quantity

    268 units