Illumina recalls

Illumina appears in 9 official U.S. recall notices indexed by RecallRadar, most recently on 2025-12-10.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, RE…
  FDA Device · Class II · 2025-12-10 · Illumina
• MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software
  FDA Device · Class II · 2023-06-28 · Illumina
• NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
  FDA Device · Class II · 2023-06-28 · Illumina
• illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
  FDA Device · Class II · 2022-06-22 · Illumina
• illumina Model NextSeq 550 Dx REF 20005715
  FDA Device · Class II · 2022-06-22 · Illumina
• Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
  FDA Device · Class II · 2022-04-06 · Illumina
• Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the pro…
  FDA Device · Class II · 2014-12-31 · Illumina
• Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform
  FDA Device · Class III · 2014-12-31 · Illumina
• Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform
  FDA Device · Class II · 2014-09-17 · Illumina