Class II U.S. Food and Drug Administration

Illumina, Inc. NovaSeq 6000Dx including Dragen Server recall: Retrospectively reported correction for an instrument intended for targeted

Recall published 18 days ago

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0068-2027
Published
October 7, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Illumina, Inc.
Product type
Medical devices
Units affected
80
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
00816270020637

Products covered by this recall

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

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00816270020637

Model or item number

On the rating label, the box or the instruction sheet.

  • 20068232
  • 20086130 — Catalog
  • UDI-DI

Serial number

On the rating plate, often next to the date of manufacture.

  • 20068232
  • 00816270020637
  • ADX00020
  • ADX0011

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Illumina, Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Illumina, Inc. — 5200 Illumina Way, San Diego, CA, 92122-4616

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Illumina, Inc. medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00816270020637; model number 20068232, 20086130 — Catalog, UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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