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Completed

illumina Model NextSeq 550 Dx REF 20005715

FDA Recall Z-1260-2022 · Posted None

Recalling FirmIllumina, Inc.
Recall StatusCompleted
Product CodePFF
Date Initiated2022-05-03
Product Quantity799 instruments

Reason for Recall

cybersecurity vulnerability

Firm 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]

Root Cause

Software in the Use Environment

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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