The Recall Desk
HighFDA (Devices)·Z-0884-2026·Announced 2025-12-10

[pending] Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Out

Pending LLM rewrite. Source: FDA_DEVICE Z-0884-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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 during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.

The recalled product

Product
Reagent 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: 2002
Manufacturer
Illumina, Inc.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • A185016-3
  • A183951-3
  • A182816-3
  • A183339-3
  • A182533-3
  • A183950-3
  • A184531-3
  • A182413-3
  • A184058-3
  • A183613-3
  • A183211-3
  • A183612-3
  • A183826-3
  • A182302-3
  • A183449-3
  • A182298-3
  • A182532-3
  • A182299-3
  • A183830-3
  • A183118-3

Distribution

Distributed nationwide across the United States.

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