FDA recall, , Moderate risk
Illumina NovaSeq 6000Dx and DRAGEN Server for NextSeq 550Dx
The NovaSeq 6000Dx and Illumina Dragen Server have a security vulnerability.
Summary by Recall Canary from the FDA notice
What happened
Illumina, Inc. of San Diego, California, retrospectively reported a correction for the NovaSeq 6000Dx including DRAGEN Server and the Illumina DRAGEN Server for NextSeq 550Dx, because the server has a security vulnerability. The instrument is intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays.
The correction began on September 17, 2024, and was added to the FDA's Enforcement Report on October 1, 2026, with distribution in the United States and internationally.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
- UDI-DI
- 20068232
- 00816270020637
- 20086130
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Texas, Kansas, North Carolina, California, Utah, KA, Massachusetts, New Jersey, Maryland 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.
- Company
- Illumina, Inc.San Diego, California
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99585
- Recall number
- Z-0068-2027
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
