Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Illumina with 10 device recalls and 4 510(k) clearances. The most recent is a device recall dated Nov 13, 2014: Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 13, 2014 | 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 pClass II · It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal K | Device recalls |
| Nov 6, 2014 | Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.Class III · Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic | Device recalls |
| Jul 28, 2014 | Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a seClass II · A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as | Device recalls |
| Nov 19, 2013 | ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAYK124006 · PFR | 510(k) clearances |
| Nov 19, 2013 | MISEQDX UNIVERSAL KIT 1.0DEN130042 · PFT | 510(k) clearances |
| Nov 19, 2013 | ILLUMINA MISEQDX PLATFORMDEN130011 · PFF | 510(k) clearances |
| Nov 19, 2013 | ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAYK132750 · PFS | 510(k) clearances |
| Apr 28, 2010 | ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR IIK093129 · NPQ | 510(k) clearances |
| Apr 28, 2010 | ILLUMINA BEADXPRESS SYSTEMK093128 · NSU | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
