Illumina, Inc.: Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, RE

Company / brand

Illumina, Inc.

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 Reagent Kit v2.5 (300 cycles) IVD, REF: 20064344/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD, 20064345/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD, 20064346/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; /FLOWCELL, FIT FLUIDICS TESTING, REF: 15050205

Reason / hazard

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.

Classification

Class II

Status

Ongoing

Distribution / sold at

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, NO, FI, JP, SG, LU, AT, AE, ZA, PT, LT, SE.

Recall initiated

2025-10-28

Code info

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)

Product quantity

11916

Voluntary mandated

Voluntary: Firm initiated

City

San Diego

State

CA

Country

United States

Event id

97913

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