Illumina, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 6
- Inspections
- 7
- Compliance Actions
- 0
Known Names
illumina, illumina-inc-hayward, illumina-singapore-pte, illumina inc hayward, illumina singapore pte
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0884-2026 | Class II | Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Out | October 28, 2025 |
| Z-1977-2023 | Class II | MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software. | April 5, 2023 |
| Z-1976-2023 | Class II | NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software | April 5, 2023 |
| Z-1260-2022 | Class II | illumina Model NextSeq 550 Dx REF 20005715 | May 3, 2022 |
| Z-1259-2022 | Class II | illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20 | May 3, 2022 |
| Z-0854-2022 | Class II | Illumina NextSeq 550Dx, REF: 20005715, CE, IVD | February 22, 2022 |
| Z-0849-2015 | Class II | Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set o | November 13, 2014 |
| Z-0850-2015 | Class III | Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on th | November 6, 2014 |
| Z-2611-2014 | Class II | Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Pro | July 28, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN130042 | MISEQDX UNIVERSAL KIT 1.0 | November 19, 2013 |
| K132750 | ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY | November 19, 2013 |
| K124006 | ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY | November 19, 2013 |
| DEN130011 | ILLUMINA MISEQDX PLATFORM | November 19, 2013 |
| K093128 | ILLUMINA BEADXPRESS SYSTEM | April 28, 2010 |
| K093129 | ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II | April 28, 2010 |