The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1976-2023·Announced 2023-06-28

NextSeq 550Dx sequencing instruments recalled for cybersecurity software vulnerability

Illumina is recalling 1,067 NextSeq 550Dx sequencing instruments due to a cybersecurity vulnerability in the Universal Copy Service software. The affected instruments have been distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The source identifies a cybersecurity vulnerability in medical device software without reported illnesses or injuries. This constitutes a risk-of-harm product where injury has not yet been reported, warranting a High severity rating per the rubric.

Plain-English summary

Illumina, Inc. is recalling 1,067 NextSeq 550Dx Instruments (Catalog # 20005715) that contain affected versions of the Universal Copy Service software. These instruments are used for genomic sequencing.

The FDA has classified this as a Class II recall due to a cybersecurity vulnerability identified in the Universal Copy Service software. Affected software versions are 1.4.2.927, 1.6.3.1423, and 2.7.2.4320 (UDI-DI: 00816270020125).

The recalled instruments have been distributed worldwide, including throughout the United States and to numerous countries including Australia, Canada, China, Japan, South Korea, the United Kingdom, and others.

Customers with affected NextSeq 550Dx instruments should contact Illumina for guidance on the cybersecurity vulnerability and any necessary remediation steps.

The recalled product

Product
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Manufacturer
Illumina, Inc.
Category
Medical Device — Sequencing Instrument
Hazard
Affected units
1,067

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)

  • Impacted UCS Versions: 1.4.2.927
  • 1.6.3.1423
  • 2.7.2.4320/ UDI-DI: (00)816270020125

Distribution

Distributed nationwide across the United States.

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 →

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