FDAFebruary 22, 2022device
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Completed
Brands named
illumina
UPCs
00816270020125
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
- FDANextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software2023-04-05
- 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
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