Official recall notice
NovaSeq 6000Dx including DRAGEN Server Recall (Oct 2026)
Product: NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
- Recall date
- 2026-10-07
- Brand
- Illumina, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product description
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.
Affected products
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