NextSeq 550Dx Reagent Kits Recalled for Gasket Defect and Leakage Risk

Agency Publication Date: December 4, 2025

Summary

Illumina, Inc. is recalling 11,916 reagent kits containing flow cells used with the NextSeq 550Dx sequencing instrument. The flow cells in these kits have defective gaskets that may fail during DNA sequencing runs, leading to fluid leaks. These leaks can result in run failures with no usable data, instrument damage due to clogs, and potential exposure to toxic reagents.

Risk

Defective gaskets in the flow cells can leak hazardous liquids during operation. This poses a risk of direct toxic substance exposure to laboratory personnel and can cause the instrument to malfunction or fail to produce critical diagnostic sequencing data.

What You Should Do

This recall involves Illumina NextSeq 550Dx Reagent Kits (High Output and Mid Output v2.5) containing flow cells with quality-related gasket issues.
Check the model (REF) and lot numbers on your reagent kit packaging to determine if your supply is affected. See the Affected Products section below for the full list of affected codes.
Stop using any affected reagent kits immediately to avoid instrument damage or potential hazardous leaks.
Contact Illumina, Inc. or your authorized distributor to arrange for the return, replacement, or correction of the recalled kits.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD

Variants: 75 cycles

Model / REF:

20028870

20031098

Lot Numbers:

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

UDI:

00816270020132

NextSeq 550Dx HO FC Cart v2.5

Product: NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD

Variants: 300 cycles

Model / REF:

20028871

20026365

Lot Numbers:

A182717-3

A182051-3

A179804-3

A183343-3

UDI:

00816270020118

NextSeq 550Dx HO FC Cart v2.5

Product: CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD

Variants: 75 cycles, China Distribution

Model / REF:

20064341

20062316

Lot Numbers:

A183402-4

A183550-4

UDI:

006975709330014

Product: CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD

Variants: 300 cycles, China Distribution

Model / REF:

20064344

20062316

Lot Numbers:

A186185-4

A183170-4

A183404-4

A183555-4

A183557-4

UDI:

006975709330038

Product: CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD

Variants: 150 cycles, China Distribution

Model / REF:

20064345

20062530

Lot Numbers:

A186074-4

A183278-4

A183405-4

A184005-4

UDI:

006975709330045

Product: CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD

Variants: 300 cycles, China Distribution

Model / REF:

20064346

20062530

Lot Numbers:

A185054-4

A183279-4

A183409-4

A183568-4

A183569-4

A183570-4

A184776-4

UDI:

006975709330052

Product: FLOWCELL, FIT FLUIDICS TESTING

Model / REF:

15050205

Lot Numbers:

20935999

20956354

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97913

Status: Active

Manufacturer: Illumina, Inc.

Sold By: Illumina, Inc.; Laboratory supply distributors

Manufactured In: United States

Units Affected: 11916

Distributed To: Pennsylvania, New Jersey, California, North Carolina, Utah, Illinois, Maryland, New York, Virginia, West Virginia, South Dakota, Texas, Alabama, South Carolina, Tennessee, Kentucky, Michigan

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves Illumina NextSeq 550Dx Reagent Kits (High Output and Mid Output v2.5) containing flow cells with quality-related gasket issues.

Check the model (REF) and lot numbers on your reagent kit packaging to determine if your supply is affected. See the Affected Products section below for the full list of affected codes.

Stop using any affected reagent kits immediately to avoid instrument damage or potential hazardous leaks.

Contact Illumina, Inc. or your authorized distributor to arrange for the return, replacement, or correction of the recalled kits.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Affected Products

Product: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD

Variants: 75 cycles

Model / REF:

20028870

20031098

Lot Numbers:

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

UDI:

00816270020132

NextSeq 550Dx HO FC Cart v2.5

Product: NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD

Variants: 300 cycles

Model / REF:

20028871

20026365

Lot Numbers:

A182717-3

A182051-3

A179804-3

A183343-3

UDI:

00816270020118

NextSeq 550Dx HO FC Cart v2.5

Product: CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD

Variants: 75 cycles, China Distribution

Model / REF:

20064341

20062316

Lot Numbers:

A183402-4

A183550-4

UDI:

006975709330014

Product: CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD

Variants: 300 cycles, China Distribution

Model / REF:

20064344

20062316

Lot Numbers:

A186185-4

A183170-4

A183404-4

A183555-4

A183557-4

UDI:

006975709330038

Product: CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD

Variants: 150 cycles, China Distribution

Model / REF:

20064345

20062530

Lot Numbers:

A186074-4

A183278-4

A183405-4

A184005-4

UDI:

006975709330045

Product: CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD

Variants: 300 cycles, China Distribution

Model / REF:

20064346

20062530

Lot Numbers:

A185054-4

A183279-4

A183409-4

A183568-4

A183569-4

A183570-4

A184776-4

UDI:

006975709330052

Product: FLOWCELL, FIT FLUIDICS TESTING

Model / REF:

15050205

Lot Numbers:

20935999

20956354

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97913

Status: Active

Manufacturer: Illumina, Inc.

Sold By: Illumina, Inc.; Laboratory supply distributors

Manufactured In: United States

Units Affected: 11916