Thursday, June 2, 2022

Illumina vulnerability may impact patient test results

An unauthorized user could exploit the vulnerability by taking control of the Illumina sequencing instrument remotely.

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CDRH Letter to Healthcare Providers - Medical Device Safety

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Illumina Cybersecurity Vulnerability May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers

Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers about a cybersecurity vulnerability affecting the Illumina NextSeq 550Dx, MiSeqDx, NextSeq 500, NextSeq 550, MiSeq, iSeq, and MiniSeq next generation sequencing instruments.

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The Letter to Health Care Providers includes important information about this cybersecurity vulnerability, including:

  • Background on the issue and the FDA's actions to address it.
  • Recommendations on how to mitigate cybersecurity risks associated with NextSeq 550 DX, MiSeqDX, NextSeq 500, NextSeq 550, MiSeq, iSeq, and MiniSeq sequencing instruments.
  • Instructions for reporting problems to the FDA about this cybersecurity vulnerability.

Questions?

If you have questions about this letter to health care providers, contact the Division of Industry and Consumer Education 


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