FDAOctober 28, 2025device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
illumina
UPCs
008162700201250081627002013200816270020118
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.2023-04-05
- FDANextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software2023-04-05
- FDAillumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx2022-05-03
- FDAillumina Model NextSeq 550 Dx REF 200057152022-05-03
- FDAIllumina NextSeq 550Dx, REF: 20005715, CE, IVD2022-02-22
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