BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: Microscope Slide Stainer IVD Component: N/A

    Recall: Z-1919-2024 · Reported June 5, 2024

    Enforcement

    Recall Number
    Z-1919-2024
    Event ID
    94439
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Agilent Technologies
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 5, 2024
    Initiation Date
    April 2, 2024
    Classification Date
    May 29, 2024
    Address
    815 14th St Sw, Loveland, CO, 80537-6330, United States

    Description

    Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: Microscope Slide Stainer IVD Component: N/A

    Reason

    There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.

    Code Info

    Lot Code: All Lots

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, TN, MI, MD, MA, OR, AK, MO, NC, NH, GA, RI and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, Spain, Italy, Japan, Malaysia, Netherland, New Zealand, Norway, Peru, South Korea, Sweden, Switzerland, Taiwan, The United Kingdom, Algeria, Bulgaria, Costa Rica, Cyrpus, Czech Republic, Ecuador, Egypt, Estonia, Greece, Hungary, India, Iraq, Ireland, Isreal, Kenya, Kuwait, Latvia, Lebanon, Morocco, Oman, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovakia, Thailand, Turkey, Ukraine, United Arab Emirates, Vietnam.

    Quantity

    1160 devices