Illumina NextSeq 550 Genetic Sequencer Cybersecurity Vulnerability Recall
Illumina is recalling 799 NextSeq 550 Dx genetic sequencers due to a cybersecurity vulnerability in the Local Run Manager software. Affected devices have been distributed worldwide and in the United States.
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 recall affects medical diagnostic devices with a cybersecurity vulnerability, constituting a risk-of-harm product where no illnesses or injuries have been reported. Per the rubric, theoretical hazards with no reported harm have a maximum score of 3.
Plain-English summary
Illumina, Inc. is recalling 799 NextSeq 550 Dx genetic sequencing instruments (Model 20005715) due to a cybersecurity vulnerability. The vulnerability affects devices running Local Run Manager (LRM) software versions 1.3.1 through 3.0.
The recalled instruments have been distributed worldwide, including throughout the United States and in countries such as Canada, the United Kingdom, Australia, Germany, Japan, South Korea, and many others. These devices are used for genetic sequencing in clinical diagnostic and research laboratory settings.
Customers who own or operate affected NextSeq 550 Dx instruments should contact Illumina for information regarding software updates or patches to address the identified cybersecurity vulnerability.
The recalled product
- Product
- illumina Model NextSeq 550 Dx REF 20005715
- Manufacturer
- Illumina, Inc.
- Affected units
- 799
Distribution
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
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