Reported Jun 22, 2022 · Completed

illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx

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 REF DX-410-1001 ModelMiSeq
  • Dx illumina REF 15036706 ModelMiSeq
  • Dx illumina REF 20014053 ModelMiSeq Dx
Lot codes and dates
  • Model Numbers
    • DX-410-1001
    • 15036706
    • 20014053
  • UDI-DI Code00816270020002 00816270020699 All
  • Instruments containing Software versionv.1.3.1 to 3.0
  • Installed Product IDU.S.:

    348 of 348 codes

    • M71006-20014737
    • M70955-20014737
    • M70992-20014737
    • M70999-20014737
    • M70957-20014737
    • M70989-20014737
    • M70983-20014737
    • M70979-20014737
    • M70971-20014737
    • M70977-20014737
    • M70968-20014737
    • M70938-20014737
    • M70951-20014737
    • M70770-20014737
    • M70956-20014737
    • M70958-20014737
    • M70946-20014737
    • M70939-20014737
    • M70922-20014737
    • M70905-20014737
    • M70932-20014737
    • M70904-20014737
    • M70925-20014737
    • M70894-20014737
    • M70906-20014737
    • M70892-20014737
    • M70899-20014737
    • M70897-20014737
    • M70865-20014737
    • M70882-20014737
    • M70879-20014737
    • M70883-20014737
    • M70868-20014737
    • M70880-20014737
    • M70878-20014737
    • M70864-20014737
    • M70858-20014737
    • M70861-20014737
    • M70797-20014737
    • M70842-20014737
    • M70843-20014737
    • M70855-20014737
    • M70848-20014737
    • M70840-20014737
    • M70826-20014737
    • M70818-20014737
    • M70822-20014737
    • M70827-20014737
    • M70815-20014737
    • M70296-15037414
    • M70813-20014737
    • M70814-20014737
    • M70810-20014737
    • M70799-20014737
    • M70809-20014737
    • M70803-20014737
    • M70804-20014737
    • M70805-20014737
    • M70806-20014737
    • M70808-20014737
    O.US.:

    654 of 654 codes

    • M71012-20014737
    • M71013-20014737
    • C70341-20014054
    • M71010-20014737
    • M71005-20014737
    • M71009-20014737
    • C70386-20014054
    • C70408-20014054
    • M71007-20014737
    • C70376-20014054
    • M70980-20014737
    • C70349-20014054
    • M70981-20014737
    • M71008-20014737
    • M71004-20014737
    • M71003-20014737
    • M70982-20014737
    • C70395-20014054
    • C70409-20014054
    • M70996-20014737
    • M70991-20014737
    • M71000-20014737
    • M70990-20014737
    • C70361-20014054
    • M70975-20014737
    • M70997-20014737
    • M70994-20014737
    • C70403-20014054
    • C70407-20014054
    • C70398-20014054
    • M70993-20014737
    • C70404-20014054
    • M70998-20014737
    • C70384-20014054
    • M70970-20014737
    • M70965-20014737
    • M70969-20014737
    • C70204-20014054
    • C70401-20014054
    • C70402-20014054
    • C70400-20014054
    • M70984-20014737
    • C70365-20014054
    • M70963-20014737
    • M70976-20014737
    • M70959-20014737
    • M70988-20014737
    • C70324-20014054
    • C70375-20014054
    • C70385-20014054
    • C70138-20014054
    • C70155-20014054
    • C70334-20014054
    • M70974-20014737
    • M70962-20014737
    • M70985-20014737
    • M70972-20014737
    • M70950-20014737
    • C70387-20014054
    • M70966-20014737
Amount recalled
1,014 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.

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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.