BEUDAMED
    FDA Recall Completed

    illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx

    Recall: Z-1259-2022 · Initiated May 3, 2022

    Recall

    Recall Number
    Z-1259-2022
    Event Number
    90160
    Firm
    Illumina, Inc.
    FEI Number
    3003218906
    Product Code
    PFF
    Status
    Completed
    Root Cause
    Software in the Use Environment
    Initiated
    May 3, 2022
    Address
    5200 Illumina Way, San Diego, CA, 92122-4616

    Description

    illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx

    Reason

    cybersecurity vulnerability

    Action

    On 05/03/2022, Illumina sent via email an "Urgent Medical Device Recall" Letter to customer informing them the cybersecurity vulnerability impacting the NextSeq 550 Dx and MiSeq Dx instruments with software versions 1.3 to 3.1 of the Local Run Manager (LRM) software installed. Customers are also being informed that Illumina has developed a software patch to protect against the exploitation of the vulnerability. Installation of the software patch will block remote access to the LRM web User Interface (web UI). For NextSeq 550Dx and MiSeq Dx instruments connected to the internet, the software patch is available for immediate download through a secure portal. Illumina is currently providing the website address to impacted customers and regulatory authorities only. Illumina recommends that customers download and install the software patch on their instrument(s) promptly. For affected NextSeq 550Dx and MiSeq Dx instruments not connected to the internet, Illumina has developed other options for the installation of the software patch. Impacted customers should contact Tech Support promptly to obtain information about these options. NextSeq 550Dx and MiSeq Dx instruments that have dual boot mode, the customers must install the software patch separately in each mode (Dx mode and RUO mode) of each instrument. It is also important for the customer to install the software patch on any stand-alone instances of the off-instrument LRM for RUO mode on the Dx instruments. Illumina will ask the customer to complete the Urgent Medical Device Recall verification form to confirm receipt of this notification and verify the patch was installed. We will ask the customer to return the form to Technical Support. For questions, email - [email protected]

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI, and WV. The countries of Algeria, Australia, Austria, Belgium, Bulgaria, Bosnia/Herzegovina, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Guatemala, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam.

    Quantity

    1,014 instruments