Illumina MiSeq Dx Instrument Software Cybersecurity Recall

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Recalling firmIllumina, Inc.5200 Illumina Way · San Diego, CA 92122-4616

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✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

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.

✎ GovInfoNow

Questions people ask

Is this recall affecting my MiSeq Dx instrument?

Yes, if your instrument has Universal Copy Service (UCS) software version 2.5.0 or the specific serial numbers listed in the recall notice.

What should I do if I have the affected software?

Check your software version and serial number to confirm if you are affected. The recall does not specify a remedy.

How can I get more information about this recall?

Contact Illumina directly for more details about the recall and affected units.

Take action

Contact Illumina

We’ve drafted a message you can send Illumina to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1977-2023 — Illumina Illumina

Hello,

I own a Illumina that is covered by recall Z-1977-2023 from Illumina.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Illumina, Inc. recalls MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.

Recall notice