NextSeq 550Dx Reagent Kits (Illumina) – Flow Cell Compatibility (2025)
Medical device flow cells may leak during runs, potentially causing data loss or toxic substance exposure.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 v2.5, 75 Cycles, REF: 20031098; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871/NextSeq 550Dx HO FC Cart v2.5, 300 Cycles, REF: 20026365; CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20064341/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx High Output Re
Brand
Illumina, Inc.
Lot Codes / Batch Numbers
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), 20028871/20026365/00816270020118(A182717-3, A182051-3, A179804-3, A183343-3), 20064341/20062316/006975709330014(A183402-4, A183550-4), 20064344/20062316/006975709330038(A186185-4, A183170-4, A183404-4, A183555-4, A183557-4), 20064345/20062530/006975709330045(A186074-4, A183278-4, A183405-4, A184005-4), 20064346/20062530/006975709330052(A185054-4, A183279-4, A183409-4, A183568-4, A183569-4, A183570-4, A184776-4), 15050205(20935999, 20956354)
Products Sold
NextSeq 550Dx UDI-DI: 00816270020125. Kit REF/Flow Cell REF/UDI-DI(Lot): 20028870/20031098/00816270020132(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); 20028871/20026365/00816270020118(A182717-3, A182051-3, A179804-3, A183343-3); 20064341/20062316/006975709330014(A183402-4, A183550-4); 20064344/20062316/006975709330038(A186185-4, A183170-4, A183404-4, A183555-4, A183557-4); 20064345/20062530/006975709330045(A186074-4, A183278-4, A183405-4, A184005-4); 20064346/20062530/006975709330052(A185054-4, A183279-4, A183409-4, A183568-4, A183569-4, A183570-4, A184776-4); 15050205(20935999, 20956354)
Illumina, Inc. is recalling Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Outp due to An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 10/28/2025, recall notices were emailed to customers who were asked to do the following: Dispose of reagents per local regulations. See Instrument Reference Guide: https://support.illumina.com/downloads/nextseq-550dx-instrument-reference-guide-1000000009513.html Illumina requests that this notice be communicated to all relevant personnel within your organization and to any external organization that has received the potentially affected reagent kits. If you experienced a run failure in a previous run using an affected flow cell, or experience leaking issues please contact Illumina Technical Support at techsupport@illumina.com Complete and return the verification form via email to techsupport@illumina.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026