Reported Dec 10, 2025 · Ongoing
Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument
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?
Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument
7 products · 40 lot codes
20031098NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles
- Flow Cell REF
20031098
24 recalled lot codes
00816270020132A184824-3A185016-3A183951-3A182816-3A183339-3A182533-3A183950-3A184531-3A182413-3A184058-3A183613-3A183211-3A183612-3A183826-3A182302-3A183449-3A182298-3A182532-3A182299-3A183830-3A183118-3A182301-3A184359-3A184727-3)
20026365NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871/NextSeq 550Dx HO FC Cart v2.5, 300 Cycles
- Flow Cell REF
20026365
4 recalled lot codes
00816270020118A182717-3A182051-3A179804-3A183343-3)
20062316CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20064341/CN NEXTSEQ 550Dx HO FLOW CELL V2.5
- Flow Cell REF
20062316
2 recalled lot codes
006975709330014A183402-4A183550-4)
20062316CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064344/CN NEXTSEQ 550Dx HO FLOW CELL V2.5
- Flow Cell REF
20062316
2 recalled lot codes
006975709330014A183402-4A183550-4)
Page 1 of 2
- Amount recalled
- 11916
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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