BEUDAMED
    FDA Recall Completed

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

    Recall: Z-1977-2023 · Initiated April 5, 2023

    Recall

    Recall Number
    Z-1977-2023
    Event Number
    92233
    Firm
    Illumina, Inc.
    FEI Number
    3003218906
    Product Code
    PFF
    Status
    Completed
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    April 5, 2023
    Posted
    June 16, 2023
    Address
    5200 Illumina Way, San Diego, CA, 92122-4616

    Description

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

    Reason

    Cybersecurity vulnerability concerning the software used for sequencing instruments.

    Action

    On April 5, 2023, Illumina issued a "Urgent Medical Device Recall" Notification via XXX. Illumina ask consignees to take the following actions: 1. Download & Install Software Patch: For Each Instrument Connected to the Internet: 2. Change UCS User Configuration(s): Change the UCS User configuration to standard user (with no administrator permissions) by following the instructions available in the customer communication. 3. Complete and return the Verification Form after carrying out all the steps in the instructions provided on your specific instrument(s) identified as affected in Table 1. 4. If you experience an adverse event due to this vulnerability with the use of any of the affected products, please report it to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. You can complete and submit the report online at www.fda.gov/medwatch/report.htm.

    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