Illumina Cybersecurity Vulnerability Advisory Issued to Healthcare Providers

The Cybersecurity and Infrastructure Agency (CISA) and Food and Drug Administration (FDA) have issued advisories to healthcare providers regarding a cybersecurity vulnerability affecting Illumina medical devices.

The FDA website released a statement on June 2nd warning laboratory personnel and healthcare providers of the the cybersecurity vulnerability associated with the Illumina software, which includes the Illumina NextSeq 550Dx, the MiSeqDx, the NextSeq 500, NextSeq 550, MiSeq, iSeq and MiniSeq, next generation sequencing instruments.

According to the statement, the cybersecurity vulnerability impacts the Local Run Manager (LRM) software and could allow unauthorized users to exploit the vulnerability by taking over instrument controls remotely and accessing the system to alter settings, configurations, software or data on the instrument or customer’s network.

The vulnerability may also allow unauthorized users to alter the instruments intended for clinical diagnosis, including causing the instruments to produce incorrect or no results, altered results, or even a potential data breach.

The CISA ICS Advisory (ICSA-22-153-02) provides a more technical overview of the vulnerability, including a detailed list of the affected products outlined below.

The following devices and instruments using LRM software are affected:

Illumina In Vitro Diagnostic (IVD) Devices

• NextSeq 550Dx: LRM Versions 1.3 to 3.1
• MiSeq Dx: LRM Versions 1.3 to 3.1

Researcher Use Only (ROU) Instruments

• NextSeq 500 Instrument: LRM Versions 1.3 to 3.1
• NextSeq 550 Instrument: LRM Versions 1.3 to 3.1
• MiSeq Instrument: LRM Versions 1.3 to 3.1
• iSeq 100 Instrument: LRM Versions 1.3 to 3.1
• MiniSeq Instrument: LRM Versions 1.3 to 3.1

The good news is that Illumina has developed a software patch to remediate the vulnerability, which is available at https://support.illumina.com/downloads/illumina-local-run-manager-1.0.html. In addition to downloading the patch, the FDA recommends impacted organizations to take the following actions if applicable.

• Review the Urgent Safety Notification or Product Quality Notification (for RUO Customers) sent by Illumina on May 3, 2022, to affected customers. If you did not receive a notification from Illumina, but believe you should have, please contact [email protected].
• Immediately download and install the software patch (Dx mode and RUO mode) on every affected instrument, including each stand-alone instance of the off-instrument LRM for RUO mode on the Dx instruments, while connected to the internet.
• Contact [email protected] for instructions on other ways to install the software patch if you are not connected to the internet.
• Immediately contact [email protected] if you suspect your instrument may have been compromised by an unauthorized user.

CISA has provided additional mitigation recommendations to minimize the risk of exploitation of this vulnerability that include:

• Minimizing network exposure for all control system devices and/or systems, and ensuring they are not accessible from the Internet.
• Locating control system networks and remote devices behind firewalls and isolating them from the business network.
• Using secure methods, such as Virtual Private Networks (VPNs) when remote access is required, recognizing VPNs may have vulnerabilities and should be updated to the most current version available. Also recognizing VPN is only as secure as its connected devices.

Related Links

• FDA - Illumina Cybersecurity Vulnerability May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers
• CISA ICS-CERT Advisories – ICS Advisory (ICSA-22-153-02) Illumina Local Run Manager

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