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Illumina, Inc.

6 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx recall (Z-0884-2026)Illumina, Inc.2025-12-04
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software recall (Z-1976-2023)Illumina, Inc.2023-06-16
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software. recall (Z-1977-2023)Illumina, Inc.2023-06-16
Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is recall (Z-0849-2015)Illumina Inc2014-12-23
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for recall (Z-0850-2015)Illumina Inc2014-12-23
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platfo recall (Z-2611-2014)Illumina Inc2014-09-09

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Every clearance here is in the API, with alerts when new ones post.