Illumina, Inc.
Illumina, Inc. holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2013, with 9 FDA device recalls on record.
Top product codes for Illumina, Inc.
FDA recalls by Illumina, Inc.
- Z-0884-2026 — 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
- Z-1976-2023 — NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
- Z-1977-2023 — MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
- Z-1260-2022 — illumina Model NextSeq 550 Dx REF 20005715
- Z-1259-2022 — illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
- Z-0854-2022 — Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
- Z-0849-2015 — 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 processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx instrument.
- Z-0850-2015 — Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
- Z-2611-2014 — Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Illumina, Inc.
- DEN130011 — ILLUMINA MISEQDX PLATFORM
- DEN130042 — MISEQDX UNIVERSAL KIT 1.0
- K124006 — ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
- K132750 — ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
- K093128 — ILLUMINA BEADXPRESS SYSTEM
- K093129 — ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II
Data sourced from openFDA. This site is unofficial and independent of the FDA.