Z-0068-2027

NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx...

Name: Z-0068-2027 NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx...
Creator: Illumina, Inc.
Published: 2024-09-17
License: https://open.fda.gov/license/

Illumina, Inc. / initiated 2024-09-17 / Open, Classified

FDA source

Recall record

Recall number: Z-0068-2027
Status: Open, Classified
Initiated: 2024-09-17
Posted: 2026-10-01
Recalling firm: Illumina, Inc.
Product: NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
Product code: PFF High Throughput Dna Sequence Analyzer
Reason for recall: 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.
FDA root cause: Software design
Action: On 9/17/2024, and 1/16/2025 field safety notices were emailed to customers who were asked to take actions on webpage: https://support.illumina.com/support-content/bmc.html Customers were also asked to complete and return the Verification Form via email to [email protected] This email can also be used to ask questions or to report potentially compromised servers.
Quantity in commerce: 80
Distribution: 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.
Product codes and lots: Catalog/UDI-DI/Serial Numbers: 20068232/00816270020637/ADX00020, ADX00114, ADX00121, ADX00124, ADX00147, ADX00151, ADX00139, ADX00105, ADX00103, ADX00108, ADX00104, ADX00106, ADX00101, ADX00115, ADX00111, ADX00112, ADX00117, ADX00119, ADX00116, ADX00118, ADX00125, ADX00126, ADX00131, ADX00120, ADX00128, ADX00138, ADX00142, ADX00143, ADX00144, ADX00150, ADX00146, ADX00141, ADX00133, ADX00134, ADX00122, ADX00127, ADX00130, ADX00135, ADX00140, ADX00136, ADX00137, ADX00148, ADX00149, ADX00152, ADX00153. 20086130/ACN7003517, ACN7003523, ACM5003172, ACMC007033, ACN7003530, ACM6002504, ACM5003179, ACM4005610, ACN7003516, ACN1003268, ACN1003269, ACN1003262, ACM6002503, ACN7003532, ACN1003255, ACN7003531, ACN7003518, ACN1003258, ACN1003248, ACM9002241, ACM5002946, ACM9002243, ACM6002498, ACM6002015, ACN1003254, ACN1003271, ACN1003257, ACM6002494, ACMC007031, ACMC007048, ACN1003259, ACN1003256, ACN8002480, ACO2000280, ACO7001263

Product code PFF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-09. View this recall on fda.gov (opens on fda.gov)