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Illumina, Inc. recall records

1 reported ongoing

6 records in this archive. Latest source date Oct 28, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v...

An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run fa...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of PA, NJ, CA, NC, UT, IL, MD, NY, VA, WV, SD, TX, AL, SC, TN, KY, MI and the countries of DK, SA, FR, DE, IT, CN, PL, GB, T...

Official source
FDA device enforcement

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

Cybersecurity vulnerability concerning the software used for sequencing instruments.

Class IIReported 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 F...

Official source
FDA device enforcement

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

Cybersecurity vulnerability concerning the software used for sequencing instruments.

Class IIReported 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 F...

Official source
FDA device enforcement

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

cybersecurity vulnerability

Class IIReported completed

Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, ...

Official source
FDA device enforcement

Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inop...

Class IIReported completed

Distribution: US: PA, WA, CA, MI, FL, MD, AR, UT NC, Fl, IL, NE, NJ, TN, NY, IN, CO, GA, OK, TX, CT, SD, NM, VA, AL, LA, SC, WV, OR, IA, AZ, MN OUS: Australia Austria Belgium Chile China Denm...

Official source

Reasons in these listed records

  • An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may res...
  • Cybersecurity vulnerability concerning the software used for sequencing instruments.
  • cybersecurity vulnerability
  • There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable.

These examples come from this result page and are not a ranking of every recall reason.

Checking Illumina, Inc.

Is there a recall on illumina, inc. right now?

This archive contains 6 records, including 1 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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