Illumina, Inc.
San Diego, CA, US
Illumina, Inc. appears in FDA device records in San Diego, CA. FDA records list 6 510(k) clearances between and , 34 PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Illumina, Inc. between 2010 and 2013. The busiest year on record is 2013, with 4. The most recent is 2013, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 2 |
| 2013 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K132750 | ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY | PFS | Substantially Equivalent | |
| K124006 | ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY | PFR | Substantially Equivalent | |
| DEN130042 | MISEQDX UNIVERSAL KIT 1.0 | PFT | Unknown | |
| DEN130011 | ILLUMINA MISEQDX PLATFORM | PFF | Unknown | |
| K093129 | ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II | NPQ | Substantially Equivalent | |
| K093128 | ILLUMINA BEADXPRESS SYSTEM | NSU | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003218906 | 3003218906 | Illumina, Inc. | 5200 Illumina Way, San Diego, CA 92122 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- SCUDna And Rna Oncology Controls
- PFFHigh Throughput Dna Sequence Analyzer
- NSUInstrumentation For Clinical Multiplex Test Systems
- PQPNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- PFTReagents For Molecular Diagnostic Test Systems
- PFRSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
- PFSSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
- NPQTest, Factor V Leiden Mutations, Genomic Dna Pcr
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 | 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. | Class II | Open, Classified | |
| Z-1977-2023 | MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software. | Cybersecurity vulnerability concerning the software used for sequencing instruments. | Class II | Completed | |
| Z-1976-2023 | NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software | Cybersecurity vulnerability concerning the software used for sequencing instruments. | Class II | Completed | |
| Z-1260-2022 | illumina Model NextSeq 550 Dx REF 20005715 | cybersecurity vulnerability | Class II | Completed | |
| Z-1259-2022 | illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx | cybersecurity vulnerability | Class II | Completed | |
| Z-0854-2022 | Illumina NextSeq 550Dx, REF: 20005715, CE, IVD | There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable. | Class II | Completed | |
| 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. | It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot report insertions or deletions at specific genomic locations with respect to the primer. | Class II | Terminated | |
| Z-0850-2015 | Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform. | Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument. | Class III | Terminated | |
| 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. | A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain