BEUDAMED
    FDA Enforcement Class II Terminated

    CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.

    Recall: Z-1074-2019 · Reported April 10, 2019

    Enforcement

    Recall Number
    Z-1074-2019
    Event ID
    82240
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Laboratories
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2019
    Initiation Date
    February 20, 2019
    Classification Date
    March 29, 2019
    Termination Date
    August 13, 2021
    Address
    4551 Great America Pkwy, N/A, Santa Clara, CA, 95054-1208, United States

    Description

    CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.

    Reason

    There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.

    Code Info

    All serial numbers below 7765.

    Distribution

    Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chile, China, Colombia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gaza & Jericho, Germany, Greece, Guatemala, Guinea, Haiti, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania, Mexico, Moldova, Montenegro, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, St. Maarten, St. Vincent & The Grenadines, Sudan, Switzerland, Taiwan, Tanzania, Thailand, Togo, Trinidad & Tobago, Turkey, Turks & Caicos, UAE, Uganda, UK, Uruguay, Venezuela, Viet Nam, Yemen, Zambia, and Zimbabwe.

    Quantity

    6,353 units