Illumina Inc
9 recalls on record · Latest: Dec 10, 2025
Illumina Inc Recall Insight
Illumina Inc appears on 9 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.009% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 10, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.
On this page of 9 entries, severity tagging shows 0 critical, 8 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 9 of 9 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (9). The date window on this page runs from Sep 17, 2014 to Dec 10, 2025.
Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.
Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 200288…
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
illumina Model NextSeq 550 Dx REF 20005715
illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
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…
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing …
Nearby Manufacturers
Other firms with recall activity tracked in the PlainRecalls index.
Data Sources
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.