CLASS II ONGOING Device recall · Reported 7 Oct 2026 · FDA Enforcement Report

NovaSeq 6000Dx including Dragen Server recalled by Illumina

Illumina is recalling NovaSeq 6000Dx including Dragen Server, distributed nationwide in the US. The recall was initiated on 17 Sep 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog/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

Quantity recalled80

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0068-2027
FDA event ID: 99585
Recalling firm: Illumina, San Diego, CA
Classification: Class II
Status: Ongoing
Recall initiated: 17 Sep 2024
FDA classified: 1 Oct 2026
Reported: 7 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

17 Sep 2024	Recall initiated by company
1 Oct 2026	Classified by FDA	+744 days
7 Oct 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide California Kansas Massachusetts Maryland North Carolina New Jersey Texas Utah

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Illumina

All 10

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Device	CLASS II	Reagent Kits/ containing flow cells recalled by Illumina	Illumina	Potency & Assay	Nationwide
28 Jun 2023Device	CLASS II	NextSeq 550Dx Instrument recalled by Illumina	Illumina	Device Malfunction	Nationwide
28 Jun 2023Device	CLASS II	MiSeq Dx Instrument recalled by Illumina	Illumina	Device Malfunction	Nationwide
22 Jun 2022Device	CLASS II	illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model recalled	Illumina	Other	Nationwide
22 Jun 2022Device	CLASS II	illumina Model NextSeq 550 Dx REF recalled	Illumina	Other	Nationwide

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