Quick Facts at a Glance
- Recall Date
- October 28, 2025
- Hazard Level
- HIGH
- Brand
- Illumina
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Illumina
- Product type
- Reagent Kits with Flow Cells for NextSeq 550Dx
- Model numbers
- NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD, CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD, CN NEXTSEQ 550Dx HO FLOW CELL V2.5, CN NEXTSEQ 550Dx MO FLOW CELL V2.5 +1 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 28, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Illumina, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The NextSeq 550Dx is a high-throughput sequencing instrument used for sequencing DNA libraries in diagnostic workflows. The recall concerns reagent kits with flow cells that may leak due to gasket defects, risking run failures and exposure to hazardous substances.
Why This Is Dangerous
Gasket defects in flow cells can cause leaks during sequencing. Leaks may lead to clogs in instrument fluidics, data loss and potential exposure to toxic materials.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Labs may experience halted runs and data gaps. Operators must halt use of affected kits and coordinate with Illumina for refunds or replacements. The recall could affect diagnostic workflows and scheduling.
Practical Guidance
How to identify if yours is affected
- Check for UDI-DI numbers on packaging if available.
- Inspect flow cells and gasket components for signs of damage or leakage before use.
- If any match or uncertainty exists, stop using the kit and contact Illumina for instructions.
Where to find product info
Recall notices and identification information are provided by Illumina and available on the FDA enforcement page linked in the recall notice.
What timeline to expect
Refunds or replacements are generally processed within 4-8 weeks after initiating the recall.
If the manufacturer is unresponsive
- Document all communications with Illumina and healthcare providers.
- Escalate to regulatory authorities such as the FDA if the company is unresponsive.
How to prevent similar issues
- Verify recall status before using any reagent kits or flow cells in sequencing workflows.
- Maintain an up-to-date inventory of kits with their REF numbers and UDI-DI codes.
- Ask vendors for updated versions or safety alerts before purchase.
Documentation advice
Keep a copy of the recall letter, product labels, kit REF/Flow Cell REF, UDI-DI information, and all correspondence with Illumina.
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Product Details
- NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870 - NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871 - CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20064341 - CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064344 - CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD, REF: 20064345 - CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064346 - CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316 - CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530 - FLOWCELL, FIT FLUIDICS,
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 11,916 units recalled worldwide
- Variants include 75-cycle and 300-cycle HO reagent kits and CN HO/MO flow cells
- Global distribution to 11 US states (PA, NJ, CA, NC, UT, IL, MD, NY, VA, WV, SD, TX, AL, SC, TN, KY,
- MI) and numerous countries (DK, SA, FR, DE, IT, CN, PL, GB, TH, GR, VN, BE, ES, KR, AU, JP, SG, SE,
- Hazard: flow cell gasket defects may leak during runs, causing data loss and potential exposure to a
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