Cybersecurity vulnerability may present risks for patient results

U.S. Food and Drug Administration sent this bulletin at 04/27/2023 03:41 PM EDT

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CDRH Letter to Healthcare Providers - Medical Device Safety

Illumina Cybersecurity Vulnerability Affecting the Universal Copy Service Software 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 to inform health care providers and laboratory personnel about a cybersecurity vulnerability affecting the Universal Copy Service software in the Illumina MiSeqDx, NextSeq 550Dx, iScan, iSeq 100, MiniSeq, MiSeq, NextSeq 500, NextSeq 550, NextSeq 1000/2000, and NovaSeq 6000 sequencing instruments.

These instruments may be specified either for clinical diagnostic use in sequencing a person’s DNA for various genetic conditions or for research use only (RUO). At this time, the FDA and Illumina have not received any reports indicating this vulnerability has been exploited.

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The Letter to Health Care Providers includes:

Recommendations on how to mitigate risks associated with this cybersecurity vulnerability.
Background information about the issue.
Actions the FDA is taking.
Instructions for reporting problems with medical devices to the FDA.

Questions?

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

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