FDAApril 5, 2023device
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Cybersecurity vulnerability concerning the software used for sequencing instruments.
What to do
FDA enforcement status: Completed
Brands named
illumina
UPCs
816270020125
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAReagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871/NextSeq 550Dx ...2025-10-28
- FDAMiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.2023-04-05
- FDAillumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx2022-05-03
- FDAillumina Model NextSeq 550 Dx REF 200057152022-05-03
- FDAIllumina NextSeq 550Dx, REF: 20005715, CE, IVD2022-02-22
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