Home / Recalls / Illumina, Inc. / Z-0068-2027

Z-0068-2027 Class II Ongoing

Recalled by Illumina, Inc. — San Diego, CA

FDA device recall Z-0068-2027 was initiated by Illumina, Inc. on Sep 17, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 80.

Recall Details

Product Type
Devices
Report Date
Oct 7, 2026
Initiation Date
Sep 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
80

Product Description

NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130

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.

Distribution Pattern

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.

Code Information

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0068-2027
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Illumina, Inc.

  • Z-0884-2026 Class II — Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument… (Oct 28, 2025)
  • Z-1976-2023 Class II — NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service… (Apr 5, 2023)
  • Z-1977-2023 Class II — MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS)… (Apr 5, 2023)
  • Z-1260-2022 Class II — illumina Model NextSeq 550 Dx REF 20005715 (May 3, 2022)
  • Z-1259-2022 Class II — illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq… (May 3, 2022)
  • Z-0854-2022 Class II — Illumina NextSeq 550Dx, REF: 20005715, CE, IVD (Feb 22, 2022)
  • Z-0849-2015 Class II — Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx… (Nov 13, 2014)
  • Z-0850-2015 Class III — Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic… (Nov 6, 2014)
  • Z-2611-2014 Class II — Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina… (Jul 28, 2014)

FDA data resources