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.
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: 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.
- Hazard
- cybersecurity-vulnerability
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.
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