Reported Jun 28, 2023 · Completed

NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software

Illumina, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Illumina, Inc. · 5200 Illumina Way · San Diego, CA · 92122-4616

Is this the product you have?

    • NextSeq 550Dx Instrument
    • Catalog # 20005715
    • contaning Universal Copy Service software
Lot codes and dates
  • Impacted UCS Versions
    • 1.4.2.927
    • 1.6.3.1423
    • 2.7.2.4320/
  • UDI-DI(00)816270020125
Amount recalled
1067 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide
  • GA

Why it was recalled

Cybersecurity vulnerability concerning the software used for sequencing instruments.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:43 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.