PlainRecalls

Illumina, Inc.

Compiled from official public sources by the publisher.

9 recalls on record · Latest: Dec 10, 2025

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Agency notice ledger

Federal filing book Illumina, Inc. LIGHT-BOOK · SINGLE-AGENCY

#1,612 of 14,151 · 9 notices · 0.009% archive

  • BOOK 9 notices
  • RANK #1,612 of 14,151
  • SHARE 0.009% archive
  • AGENCY FDA Devices (9)
  • CAT medical devices
  • CATS 1 category
  • LATEST Dec 10, 2025
  • PHOTO 3Cs Organics LLC

Nearest notice-volume peer: 3Cs Organics LLC (0 notice gap)

Illumina, Inc. accounts for about 0.009% of the 104,423-notice archive on 9 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Illumina, Inc. compares to 14,151 recalling firms

Illumina, Inc. ranks 1,612th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Illumina, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

9 1612th of 14151 higher than 12,464 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Illumina, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Illumina, Inc. holds about 0.009% of archive notices alongside 9 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Dec 10, 2025

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 Outpu
FDA Devices Moderate Jun 28, 2023

MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
FDA Devices Moderate Jun 28, 2023

NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
FDA Devices Moderate Jun 22, 2022

illumina Model NextSeq 550 Dx REF 20005715
FDA Devices Moderate Jun 22, 2022

illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
FDA Devices Moderate Apr 6, 2022

Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
FDA Devices Moderate Dec 31, 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 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 instru
FDA Devices Low Dec 31, 2014

Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Devices Moderate Sep 17, 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.

Illumina, Inc. holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (9 here).

3Cs Organics LLC 9 4 C Foods, Corp. 9 A New Life Herbs, LLC 9 A-s Medication Solutions LLC 9 Abbott Nutrition 9

Frequently Asked Questions

How many federal recall notices name Illumina, Inc.? ▼
PlainRecalls indexes 9 distinct federal recall events naming Illumina, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Illumina, Inc. sit among other recalling firms? ▼
Illumina, Inc. ranks #1,612 of 14,151 by distinct recall-event count among 14,151 firms in this archive (88th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Illumina, Inc.'s notices? ▼
FDA Devices accounts for 9 of this firm's 9 indexed notices.
What product category dominates Illumina, Inc.'s filing book? ▼
Filings for Illumina, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Illumina, Inc.: 9 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Illumina, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026