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Lower risk Medical device recall · FDA · Published October 28, 2025

Illumina NextSeq 550Dx Reagent Kits: Flow Cell Leaks May Cause Run Failures

Illumina recalls NextSeq 550Dx High Output Reagent Kits v2.5 due to flow cell leaks that may cause run failures, instrument clogs, or toxic exposure. Affected kits include specific model numbers and cycle counts.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0884-2026Medical deviceIllumina ›
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Recalling firmIllumina, Inc.5200 Illumina Way · San Diego, CA 92122-4616
✎ GovInfoNow plain-language explainer

Illumina is recalling specific versions of NextSeq 550Dx reagent kits that contain flow cells with a quality issue. This could lead to leaks during DNA sequencing runs, causing run failures, instrument clogs, or toxic exposure to users. Read more at govinfonow.com/recall/50989-illumina-nextseq-550dx-reagent-kits-flow-cell-leaks-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/50989-illumina-nextseq-550dx-reagent-kits-flow-cell-leaks-may-cause · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0884-2026

Cite this page

“Illumina NextSeq 550Dx Reagent Kits: Flow Cell Leaks May Cause Run Failures.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50989-illumina-nextseq-550dx-reagent-kits-flow-cell-leaks-may-cause. Based on FDA recall #Z-0884-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0884-2026%22&limit=1).

The FDA announced on Oct. 28, 2025, that Illumina, Inc. is recalling NextSeq 550Dx reagent kits containing flow cells with gasket quality issues that may leak during runs. The agency said the leaks could cause run failures and potential toxic substance exposure to users.

How to tell if you have it

  • Brand: Illumina
  • Product: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098
  • Product: NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871/NextSeq 550Dx HO FC Cart v2.5, 300 Cycles, REF: 20026365
  • Product: CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20064341/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316
  • Product: CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064344/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316
  • Product: CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD, 20064345/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530
  • Product: CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD, 20064346/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530
  • Product: /FLOWCELL, FIT FLUIDICS TESTING, REF: 15050205
  • Lot codes include A184824-3, A185016-3, A183951-3, A182816-3, A183339-3, A182533-3, A183950-3, A184531-3, A182413-3, A184058-3, A183613-3, A183211-3, A183612-3, A183826-3, A182302-3, A183449-3, A182298-3, A182532-3, A182299-3, A183830-3, A183118-3, A182301-3, A184359-3, A184727-3 for REF 20028870/20031098
  • Lot codes include A182717-3, A182051-3, A179804-3, A183343-3 for REF 20028871/20026365
  • Lot codes include A183402-4, A183550-4 for REF 20064341/20062316
  • Lot codes include A186185-4, A183170-4, A183404-4, A183555-4, A183557-4 for REF 20064344/20062316
  • Lot codes include A186074-4, A183278-4, A183405-4, A184005-4 for REF 20064345/20062530
  • Lot codes include A185054-4, A183279-4, A183409-4, A183568-4, A183569-4, A183570-4, A184776-4 for REF 20064346/20062530
  • Lot codes include 20935999, 20956354 for REF 15050205
  • Units affected: 11916

The hazard

GovInfoNow's records show the hazard involves flow cell gaskets with a quality issue that may lead to leaks during runs. These leaks could cause run failures, resulting in no or insufficient data output, instrument fluidics clogs, and toxic substance exposure to the user.

Context

GovInfoNow's records show Illumina, Inc. has 3 other recalls on record since 2022-02-22. Other recent recalls of similar products include ICU Medical Oncology Kit Recall: Leaks May Cause Therapy Interruption (2026-03-24), ICU Medical Pulsator Arterial Blood Sampling Kit Recall: Cracks May Cause Blood Leakage (2025-12-19), and Medline Dialysis Kits Recall: Silicone Seal Issues May Cause Blood Flow Problems (2026-01-08).

How to tell if you have this one

Check for the NextSeq 550Dx High Output Reagent Kit v2.5 with 75 or 300 cycles. Look for model references like REF: 20028870, 20028871, 20064341, or 20064344. The kits are sold with specific UDI-DI lot numbers.

  • Brand
    Illumina
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Kit References

    Verify the kit's reference numbers, such as REF: 20028870 for 75-cycle kits or REF: 20064341 for Chinese market 75-cycle kits.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 17 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA 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, TH, GR, VN, BE, ES, IL, KR, AU, CH, BG, NL, IE, TW, TR, CZ, HU,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Illinois, Kentucky, Maryland, Michigan, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia.

Recall timeline

FDA published this recall 43 days after the firm started it.

1. Firm started the recall: Oct 28, 202512. FDA classified it Class II: Dec 4, 202523. Published in FDA’s Enforcement Report: Dec 10, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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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-0884-2026 (October 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0884-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA