Illumina MiSeq Dx Instrument Software Cybersecurity Recall
Illumina recalls MiSeq Dx instruments with Universal Copy Service software due to cybersecurity vulnerability. Affected units may have security risks.
Recall notice
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Contact the company
What happened, in plain English
Illumina is recalling MiSeq Dx instruments with specific software versions because of a cybersecurity vulnerability. This could allow unauthorized access to the instrument's data. Read more at govinfonow.com/recall/58607-illumina-miseq-dx-instrument-software-cybersecurity-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/58607-illumina-miseq-dx-instrument-software-cybersecurity-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1977-2023
Cite this page
“Illumina MiSeq Dx Instrument Software Cybersecurity Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58607-illumina-miseq-dx-instrument-software-cybersecurity-recall. Based on FDA recall #Z-1977-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1977-2023%22&limit=1).
Why it’s dangerous
The cybersecurity vulnerability in the UCS software could allow unauthorized access to the instrument's data. This might lead to potential data breaches or security compromises if not addressed.
Who’s affected
Users of Illumina MiSeq Dx instruments with Universal Copy Service (UCS) software versions 2.5.0 and the specific serial numbers listed are affected. Researchers and labs using these instruments are most at risk.
How to tell if you have this one
Check if your MiSeq Dx instrument has Universal Copy Service (UCS) software version 2.5.0 or the specific serial numbers listed in the recall notice. The catalog number is M70101.
- Brand
Illumina- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Completed- Distribution
Worldwide distribution - US Nationwide and the countries of Algeria, AU Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Egypt, FR France, GB Georgia, Germany, Guatemala, Hong Kong, Hungary, IT Italy, Japan, Latvia, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russian Fed., Saudi Arabia, SG Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, Utd. Arab Emir., Vietnam, Argentina, Aerbaijan, Belgium, Bosnia-Herz., Finland, Greece, Iceland, Ireland, Israel, Japan, Nigeria, NL Norway, Romania, Serbia, Slovakia, South Africa, T¿rkiye, Ukraine.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1976-2023 | NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software; Impacted UCS Versions: 1.4.2.927, 1.6.3.1423, 2.7.2.4320/ UDI-DI: (00)816270020125 | 1067 units |
| Z-1977-2023 | MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.; UCS Versions: UCS 2.5.0/ UDI-DI: (00)816270020002 | 740 units |
What to do — step by step
Check Software Version
Verify your MiSeq Dx instrument's software version by checking for UCS 2.5.0 or the specific serial numbers listed.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Algeria, AU Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Egypt, FR France, GB Georgia, Germany, Guatemala, Hong Kong, Hungary, IT…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1977-2023 (April 5, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1977-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.