Illumina recalls NextSeq 550Dx High Output Reagent Kits v2.5 due to flow cell leaks that may cause run failures, instrument clogs, or toxic exposure. Affected kits include specific model numbers and cycle counts.
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.
Illumina is recalling specific versions of NextSeq 550Dx reagent kits that contain flow cells with a quality issue. This could lead to leaks during DNA sequencing runs, causing run failures, instrument clogs, or toxic exposure to users.
The flow cell gaskets in these reagent kits have a quality issue that may cause leaks during DNA sequencing runs. Leaks can lead to run failures, instrument fluidics clogs, or exposure to toxic substances for the user.
Users of the NextSeq 550Dx instrument with the recalled reagent kits, particularly those in labs handling DNA sequencing for in vitro diagnostic tests. Lab technicians and researchers using these kits are most at risk.
Check for the NextSeq 550Dx High Output Reagent Kit v2.5 with 75 or 300 cycles. Look for model references like REF: 20028870, 20028871, 20064341, or 20064344. The kits are sold with specific UDI-DI lot numbers.
Verify the kit's reference numbers, such as REF: 20028870 for 75-cycle kits or REF: 20064341 for Chinese market 75-cycle kits.
The NextSeq 550Dx High Output Reagent Kits v2.5 with 75 or 300 cycles, including specific model references like REF: 20028870 and REF: 20064341.
Flow cell gaskets may leak during DNA sequencing runs, causing run failures, instrument fluidics clogs, or toxic substance exposure to users.
The recall does not specify a stop-use action; the remedy is null, so users can continue using but should check for leaks.
We’ve drafted a message you can send Illumina to request your refund or repair — edit it as you like.
Subject: Recall Z-0884-2026 — Illumina Illumina Hello, I own a Illumina that is covered by recall Z-0884-2026 from Illumina. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
