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Sign in to claim this brandIllumina, Inc.
United States·US-MF-000013476
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 5200 Illumina Way, San Diego, United States
- Website
- www.illumina.com
- —
- —
- [email protected]
- Phone
- 800-809-4566
- PRRC Contact
- Giavonna Goodman
- EUDAMED SRN
- US-MF-000013476
- FDA FEI Number
- 3003218906
- DUNS Number
- 033305264
Catalogue (53)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Praxis Extended RAS Panel | P160038 | FDA PMA | Class III | Active |
| NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles) | 20046933 | EUDAMEDFDA UDI | Class A | Active |
| NextSeq™ 550Dx Instrument | 20005715 | EUDAMEDFDA UDI | Class A | Active |
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FDA Recalls (9)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 28, 2025 | Z-0884-2026 | — | open, classified | 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. |
| Apr 5, 2023 | Z-1976-2023 | — | completed | Cybersecurity vulnerability concerning the software used for sequencing instruments. |
| Apr 5, 2023 | Z-1977-2023 | — | completed | Cybersecurity vulnerability concerning the software used for sequencing instruments. |
| May 3, 2022 | Z-1260-2022 | — | completed | cybersecurity vulnerability |
| May 3, 2022 | Z-1259-2022 | — | completed | cybersecurity vulnerability |
| Feb 22, 2022 | Z-0854-2022 | — | completed | 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. |
| Nov 13, 2014 | Z-0849-2015 | — | terminated | 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. |
| Nov 6, 2014 | Z-0850-2015 | — | terminated | 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. |
| Jul 28, 2014 | Z-2611-2014 | — | terminated | A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended |