FDA-Device2026-10-07Class IIPROCESSING DEFECT
Illumina NovaSeq 6000Dx and DRAGEN Server recalled for security vulnerability
What this means
Illumina has issued a retrospective correction for certain NovaSeq 6000Dx and DRAGEN Server instruments used in genetic testing. These devices contain a security vulnerability in the server component that could potentially allow unauthorized access. This affects 80 instruments distributed worldwide.
- Check if your facility operates one of the affected instrument serial numbers listed in the FDA notice
- Contact Illumina for instructions on addressing the security vulnerability
- Refer to the FDA notice for your specific device's catalog and serial numbers
The agency's original wording
Hazard
Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server with a security vulnerability.
Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the states of TX, KS, NC, CA, UT, KA, MA, NJ, MD and the countries of Spain, South Korea, Japan, Australia, Italy, United Arab Emirates, Sweden, United Kingdom, Czech Republic, Singapore, Austria, Poland, France, Germany, Finland, Switzerland, Slovakia.
Affected count
80
Manufactured in
5200 Illumina Way, San Diego, CA, United States
Products
NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0068-2027Want us to check the next one for you?
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