FDA Recalls MiSeq Dx Instruments for Software Cybersecurity Vulnerability
Illumina recalls 740 MiSeq Dx sequencing instruments due to a software cybersecurity vulnerability affecting the Universal Copy Service component. No patient harm reported.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves only a theoretical cybersecurity vulnerability with no reported illnesses, injuries, or confirmed exploitation. The recall appears precautionary in nature.
Plain-English summary
Illumina, Inc. is recalling 740 units of the MiSeq Dx Instrument (Catalog No. M70101) due to a cybersecurity vulnerability in the Universal Copy Service (UCS) software. The affected software versions include UCS 2.5.0.
The recalled instruments have worldwide distribution, including across the United States and to more than 40 countries including Canada, the United Kingdom, Germany, Japan, Australia, and others listed in the FDA recall notice.
No illnesses, injuries, or confirmed incidents related to this vulnerability have been reported to date. The FDA classified this as a Class II recall.
The recalled product
- Product
- MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
- Manufacturer
- Illumina, Inc.
- Affected units
- 740
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 (1)
- UCS Versions: UCS 2.5.0/ UDI-DI: (00)816270020002
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.
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