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# Illumina Cybersecurity Vulnerability: FDA
- URL: https://www.fdaweb.com/illumina-cybersecurity-vulnerability-fda/
- Published: 2022-06-02T12:00:00.000Z
- Updated: 2026-09-14T17:47:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151963

FDA says a cybersecurity vulnerability is affecting software in several Illumina next-generation sequencing instruments. An agency [statement](https://www.fda.gov/medical-devices/letters-health-care-providers/illumina-cybersecurity-vulnerability-may-present-risks-patient-results-and-customer-networks-letter?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the Illumina devices may be specified for either clinical diagnostic use in sequencing a person’s DNA or testing for various genetic conditions, or for research use only.

The notice says the vulnerability affects the local run manager software and an unauthorized user could exploit the vulnerability by: 

- taking control of the instrument remotely;
- operating the system to alter settings, configurations, software, or data on the instrument or a customer’s network; or
- affecting patient test results in the instruments intended for clinical diagnosis, including causing the instruments to provide no results or incorrect results, altered results, or a potential data breach.

FDA says Illumina has developed a software patch against the exploitation of the vulnerability and is working to provide a permanent software fix for current and future instruments. “FDA wants laboratory personnel and healthcare providers to be aware of the required actions to mitigate these cybersecurity risks,” the notice says.