Illumina recalls
Illumina appears in 10 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-07.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 10 |
|---|---|
| Published | 2014-09-17 to 2026-10-07 |
| By agency | FDA Device (10) |
| By classification | Class II (9), Class III (1) |
| By status | completed (5), terminated (3), ongoing (2) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MD, MI, MN, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, US, UT, VA, WA, WV |
Recalls
- NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232
FDA Device · Class II · 2026-10-07 · Illumina
Reason: Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server with a security vulnerability. - Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, RE…
FDA Device · Class II · 2025-12-10 · Illumina
Reason: 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… - MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software
FDA Device · Class II · 2023-06-28 · Illumina
Reason: Cybersecurity vulnerability concerning the software used for sequencing instruments. - NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
FDA Device · Class II · 2023-06-28 · Illumina
Reason: Cybersecurity vulnerability concerning the software used for sequencing instruments. - illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
FDA Device · Class II · 2022-06-22 · Illumina
Reason: cybersecurity vulnerability - illumina Model NextSeq 550 Dx REF 20005715
FDA Device · Class II · 2022-06-22 · Illumina
Reason: cybersecurity vulnerability - Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
FDA Device · Class II · 2022-04-06 · Illumina
Reason: 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 ci… - 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 pro…
FDA Device · Class II · 2014-12-31 · Illumina
Reason: 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 ge… - Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform
FDA Device · Class III · 2014-12-31 · Illumina
Reason: 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. - Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform
FDA Device · Class II · 2014-09-17 · Illumina
Reason: A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended