Reported Jun 22, 2022 · Completed

illumina Model NextSeq 550 Dx REF 20005715

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?

  • illumina Model NextSeq 550 Dx REF 20005715
Lot codes and dates
  • Model Numbers20005715
  • UDI-DI Code00816270020125 All Instruments containing Local
  • Run Manager (LRM) Software versionv.1.3.1 to 3.0
  • Installed Product IDU.S.:

    233 of 233 codes

    • NDX550779-15073937
    • NDX550504-15073937
    • NDX550732-15073937
    • NDX550287-15073937
    • NDX550802-15073937
    • NDX550691-15073937
    • NDX550656-15073937
    • NDX550725-15073937
    • NDX550736-15073937
    • NDX550754-15073937
    • NDX550151-15073937
    • NDX550996-15073937
    • NDX550916-15073937
    • NDX550420-15073937
    • NDX550715-15073937
    • NDX550726-15073937
    • NDX550729-15073937
    • NDX550730-15073937
    • NDX550712-15073937
    • NDX550722-15073937
    • NDX550660-15073937
    • NDX550603-15073937
    • NDX550601-15073937
    • NDX550595-15073937
    • NDX550553-15073937
    • NDX550568-15073937
    • NDX550579-15073937
    • NDX550586-15073937
    • NDX550590-15073937
    • NDX550561-15073937
    • NDX550522-15073937
    • NDX550535-15073937
    • NDX550563-15073937
    • NDX550485-15073937
    • NDX550547-15073937
    • NDX550552-15073937
    • NDX550560-15073937
    • NDX550537-15073937
    • NDX550531-15073937
    • NDX550532-15073937
    • NDX550533-15073937
    • NDX550501-15073937
    • NDX550503-15073937
    • NDX550474-15073937
    • NDX550445-15073937
    • NDX550432-15073937
    • NDX550378-15073937
    • NDX550369-15073937
    • NDX550374-15073937
    • NDX550115-15073937
    • NDX550370-15073937
    • NDX550376-15073937
    • NDX550381-15073937
    • NDX550361-15073937
    • NDX550257-15073937
    • NDX550313-15073937
    • NDX550288-15073937
    • 15073937NDX550261
    • NDX550207-15073937
    • NDX550149-15073937
    O.U.S.:

    577 of 577 codes

    • NDX550961-15073937
    • NDX550959-15073937
    • NDX550938-15073937
    • NDX550861-15073937
    • NDX550774-15073937
    • NDX550576-15073937
    • NDX550577-15073937
    • NDX550623-15073937
    • NDX550520-15073937
    • NDX550511-15073937
    • NDX550507-15073937
    • NDX550495-15073937
    • NDX550498-15073937
    • NDX550309-15073937
    • NDX550194-15073937
    • NDX550148-15073937
    • NDX550160-15073937
    • NDX550161-15073937
    • NDX550162-15073937
    • NDX550953-15073937
    • NDX550955-15073937
    • NDX551002-15073937
    • NDX550907-15073937
    • NDX550765-15073937
    • NDX550733-15073937
    • NDX550663-15073937
    • NDX550645-15073937
    • NDX550447-15073937
    • NDX550431-15073937
    • NDX550270-15073937
    • NDX550922-15073937
    • NDX550596-15073937
    • NDX550562-15073937
    • NDX550538-15073937
    • NDX550469-15073937
    • NDX550448-15073937
    • NDX550417-15073937
    • NDX550416-15073937
    • NDX550860-15073937
    • NDX550386-15073937
    • NDX550895-15073937
    • NDX550971-15073937
    • NDX550980-15073937
    • NDX550822-15073937
    • NDX550972-15073937
    • NDX550987-15073937
    • NDX550948-15073937
    • NDX550976-15073937
    • NDX550913-15073937
    • NDX550936-15073937
    • NDX550883-15073937
    • NDX550687-15073937
    • NDX550835-15073937
    • NDX550812-15073937
    • NDX550941-15073937
    • NDX550878-15073937
    • NDX550741-15073937
    • NDX550882-15073937
    • NDX550743-15073937
    • NDX550737-15073937
Amount recalled
799 instruments

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

Why it was recalled

cybersecurity vulnerability

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, 6:56 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.