FDA warns about Illumina NGS cybersecurity vulnerability

2016 09 02 09 36 05 93 Fda Logo V2 400

The U.S. Food and Drug Administration (FDA) on Thursday informed laboratory personnel and healthcare providers about a cybersecurity vulnerability affecting software for the Illumina NextSeq 550Dx, MiSeqDx, NextSeq 500, NextSeq 550, MiSeq, iSeq, and MiniSeq next-generation sequencing (NGS) instruments.

The instruments may be specified for research use only or for clinical diagnostic use in sequencing a person's DNA or testing for various genetic conditions.

The FDA said in a statement that because of the cybersecurity vulnerability, an unauthorized user could potentially do any of the following: take control of an instrument remotely; alter settings, configurations, software, or data on an instrument or a customer's network; impact patient test results in instruments intended for clinical diagnosis, including causing the instruments to provide no results, incorrect results, or altered results; enable a potential data breach.

Illumina has developed a software patch to protect against the exploitation of the vulnerability and is working to provide a permanent software fix for current and future instruments, the FDA said.

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