The Recall Desk
HighFDA (Devices)·Z-1259-2022·Announced 2022-06-22

Illumina MiSeq Dx Sequencing Instruments Recalled Due to Cybersecurity Vulnerability

Illumina is recalling approximately 1,014 MiSeq Dx sequencing instruments due to a cybersecurity vulnerability. The devices are distributed worldwide and throughout the United States.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall for cybersecurity vulnerability affecting diagnostic sequencing instruments. No reported illnesses, injuries, or deaths. Classified as high severity because cybersecurity vulnerabilities on medical devices represent a risk-of-harm scenario where patient-impacting functionality could be compromised, though no actual harm has been reported.

Plain-English summary

Illumina, Inc. is recalling approximately 1,014 MiSeq Dx sequencing instruments (model numbers DX-410-1001, 15036706, and 20014053) due to a cybersecurity vulnerability. The affected instruments contain software versions 1.3.1 through 3.0.

The recalled devices have been distributed to all 50 U.S. states and Washington D.C., as well as internationally to multiple countries including Canada, Australia, Japan, the United Kingdom, and many others.

The FDA classifies this as a Class II recall. Consumers with questions about whether they possess a recalled device should verify their instrument's model number and software version and contact Illumina, Inc. for information regarding remediation options.

The recalled product

Product
illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
Manufacturer
Illumina, Inc.
Category
Medical Device — Diagnostic Sequencing
Hazard
Affected units
1,014

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model Numbers: DX-410-1001
  • 15036706
  • 20014053

Distribution

Distributed nationwide across the United States.

The notice also names 43 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Illumina, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Illumina, Inc.

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Same hazard · cybersecurity vulnerability

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