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FDA, CISA: Illumina Medical Devices Vulnerable to Remote Hacking

FDA and CISA notify healthcare providers about a component used by several Illumina medical devices being affected by serious vulnerabilities that can allow remote hacking.

The US government is notifying healthcare providers and lab personnel about a component used by several Illumina medical devices being affected by serious vulnerabilities that can allow remote hacking.

On Thursday, the Cybersecurity and Infrastructure Security Agency (CISA) and the Food and Drug Administration (FDA) issued public notifications to inform organizations about the vulnerabilities affecting the Universal Copy Service (UCS) component used by several of Illumina’s genetic sequencing instruments. 

The vendor has released patches and mitigations, and published its own advisory to inform customers about the steps they have to take to prevent potential exploitation. 

The FDA said it was not aware of any attacks exploiting the vulnerabilities in the wild, but warned that a hacker could exploit them to remotely take control of a device, or to alter configurations, settings, software or data on the device or the user’s network. 

The FDA also warned that exploitation of the vulnerabilities could also impact “genomic data results in the instruments intended for clinical diagnosis, including causing the instruments to provide no results, incorrect results, altered results, or a potential data breach”.

CISA’s advisory reveals that Illumina Universal Copy Service is affected by a critical vulnerability, tracked as CVE-2023-1968, related to binding to an unrestricted IP, which can allow an unauthenticated attacker to abuse the component to listen on all IPs, including ones that accept remote connections.

The second flaw, CVE-2023-1966, is related to unnecessary privileges that can allow an unauthenticated hacker to remotely upload and execute code at the OS level.

Illumina’s iScan, iSeq, MiniSeq, MiSeq, MiSeqDx, NextSeq, and NovaSeq products are affected by the vulnerabilities. These products, used worldwide in the healthcare sector, are designed for clinical diagnostic use in sequencing a person’s DNA for various genetic conditions or for research purposes.

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“On April 5, 2023, Illumina sent notifications to affected customers instructing them to check their instruments and medical devices for signs of potential exploitation of the vulnerability,” the FDA said in its notification.

Similar notifications were issued last year by CISA and the FDA over different vulnerabilities affecting Illumina genetic analysis devices.

The FDA announced recently that it will require medical device makers to meet specific cybersecurity requirements when submitting an application for a new product.

Related: FDA Approves Use of New Tool for Medical Device Vulnerability Scoring

Related: Canon Medical Product Vulnerabilities Expose Patient Information

Related: Medical, IoT Devices From Many Manufacturers Affected by ‘Access:7’ Vulnerabilities

Written By

Eduard Kovacs (@EduardKovacs) is a contributing editor at SecurityWeek. He worked as a high school IT teacher for two years before starting a career in journalism as Softpedia’s security news reporter. Eduard holds a bachelor’s degree in industrial informatics and a master’s degree in computer techniques applied in electrical engineering.

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