BEUDAMED
    FDA Enforcement Class II Completed

    MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.

    Recall: Z-1977-2023 · Reported June 28, 2023

    Enforcement

    Recall Number
    Z-1977-2023
    Event ID
    92233
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Illumina, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 28, 2023
    Initiation Date
    April 5, 2023
    Classification Date
    June 16, 2023
    Address
    5200 Illumina Way, San Diego, CA, 92122-4616, United States

    Description

    MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.

    Reason

    Cybersecurity vulnerability concerning the software used for sequencing instruments.

    Code Info

    UCS Versions: UCS 2.5.0/ UDI-DI: (00)816270020002

    Distribution

    Worldwide distribution - US Nationwide and the countries of Algeria, AU Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Egypt, FR France, GB Georgia, Germany, Guatemala, Hong Kong, Hungary, IT Italy, Japan, Latvia, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russian Fed., Saudi Arabia, SG Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, Utd. Arab Emir., Vietnam, Argentina, Aerbaijan, Belgium, Bosnia-Herz., Finland, Greece, Iceland, Ireland, Israel, Japan, Nigeria, NL Norway, Romania, Serbia, Slovakia, South Africa, T¿rkiye, Ukraine.

    Quantity

    740 units