Illumina Inc. has agreed to pay $9.8 million to resolve allegations that it violated the False Claims Act when it sold to federal agencies certain genomic sequencing systems with cybersecurity vulnerabilities, according to a press release on July 31. Illumina is a Delaware corporation, headquartered in California, that manufactured and sold genomic sequencing systems throughout the United States.
The settlement resolves allegations that, between February 2016 and September 2023, Illumina sold government agencies genomic sequencing systems with software that had cybersecurity vulnerabilities, without having an adequate security program and sufficient quality systems to identify and address those vulnerabilities. Specifically, the United States contended that Illumina knowingly failed to incorporate product cybersecurity in its software design, development, installation, and on-market monitoring; failed to properly support and resource personnel, systems, and processes tasked with product security; failed to adequately correct design features that introduced cybersecurity vulnerabilities in the genomic sequencing systems; and falsely represented that the software on the genomic sequencing systems adhered to cybersecurity standards, including standards of the International Organization for Standardization and National Institute of Standards and Technology.
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