BEUDAMED
    FDA Enforcement Class II Terminated

    D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection, and analysis.

    Recall: Z-0695-2016 · Reported February 3, 2016

    Enforcement

    Recall Number
    Z-0695-2016
    Event ID
    72927
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bio-Rad Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 3, 2016
    Initiation Date
    December 15, 2015
    Classification Date
    January 27, 2016
    Termination Date
    May 2, 2016
    Address
    4000 Alfred Nobel Dr, N/A, Hercules, CA, 94547-1803, United States

    Description

    D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection, and analysis.

    Reason

    On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration.

    Code Info

    All codes - 2006 to present

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, Belgium, Brazil, Brunei Darussalam, China, Czech Republic, France, Germany, Greece, India, Israel, Italy, Malaysia, Maldives, New Zealand, Norway, Austria, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Thailand, and UK.

    Quantity

    165 in US, 200 Internationally