Facility

Illumina Singapore Pte. Ltd.

7 recall(s) on record — most severe on record: Class II.

Key facts

7recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3007102730
Establishment type	Manufacture Medical Device
Location	29 Woodlands Industrial Park E1 Singapore Central Singapore, SG 75771
Registration status	Active · expires 2026
Parent company	Illumina, Inc. (owner-operator 10030352)
Brand names	DRAGEN for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550Dx; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles); NovaSeq 6000Dx S2 Buffer Cartridge; Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (16 samples); DRAGEN for Illumina DNA Prep with Enrichment Dx Application for NovaSeq 6000Dx; NovaSeq 6000Dx S4 Buffer Cartridge; TruSeq Custom Amplicon Kit Dx- FFPE; NovaSeq 6000Dx Library Tube; NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles); Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (96 samples); Illumina® DNA Prep with Enrichment Dx with UD Indexes Set A (16 samples); NovaSeq 6000Dx S2 Reagent v1.5 Kit (300 cycles)

Activity by year

Recalls (7)

Devices registered here (1)

Reagents For Molecular Diagnostic Test Systems
Product code PFT (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.3800

Recalls & enforcement

Class IIOngoing2025-10-28
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…
Class IICompleted2023-04-05
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Class IICompleted2022-05-03
cybersecurity vulnerability
Class IICompleted2022-02-22
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.
Class IITerminated2014-11-13
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.
Class IIITerminated2014-11-06
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.
Class IITerminated2014-07-28
A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Illumina Singapore Pte. Ltd. (FEI 3007102730) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007102730-illumina-singapore-pte-ltd/

Not open yet

Alerts for Illumina Singapore Pte. Ltd.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.