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Illumina, Inc. FDA Recalls
6 recalls on file across devices, 0 of them Class I and 1 still open. Matched by name to ILMN.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5Class IIOct 28, 2025An instrument intended for sequencing DNA libraries with in |
| MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.Class IIApr 5, 2023Cybersecurity vulnerability concerning the software used for |
| NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service softwareClass IIApr 5, 2023Cybersecurity vulnerability concerning the software used for |
| illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Class IIMay 3, 2022cybersecurity vulnerability |
| illumina Model NextSeq 550 Dx REF 20005715Class IIMay 3, 2022cybersecurity vulnerability |
| Illumina NextSeq 550Dx, REF: 20005715, CE, IVDClass IIFeb 22, 2022There is a potential that the DNA sequence analyzer may shor |