Illumina, Inc.
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Illumina, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-12-10FDA-DeviceClass IIReagent 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 Outpu
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.
- 2023-06-28FDA-DeviceClass IIMiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Cybersecurity vulnerability concerning the software used for sequencing instruments.
- 2023-06-28FDA-DeviceClass IINextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Cybersecurity vulnerability concerning the software used for sequencing instruments.
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