Illumina, Inc.
San Diego, CA
This page shows every FDA and USDA recall linked to Illumina, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
9
Total Recalls
2014
First Recall
2025
Most Recent
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Jun 16, 2023
· Device
Completed
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Jun 16, 2023
· Device
Completed
illumina Model NextSeq 550 Dx REF 20005715
May 3, 2022
· Device
Completed
illumina REF DX-410-1001 Model: MiSeq Dx
illumina REF 15036706 Model: MiSeq Dx
illumina REF 20014053 Model:...
May 3, 2022
· Device
Completed
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Feb 22, 2022
· Device
Completed
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina...
Dec 23, 2014
· Device
Terminated
Illumina MiSeqDx Universal Kit 1.0, PN 15039608
The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents a...
Dec 23, 2014
· Device
Terminated
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform.
Product Usage:...
Sep 9, 2014
· Device
Terminated