Illumina recalled 11,916 NextSeq 550Dx reagent kits and flow cells worldwide after identifying a gasket defect that can leak during sequencing. The issue may cause run failures, no or insufficient data output, instrument fluidics clogs and potential exposure to toxic substances. Healthcare providers and users should stop using the affected kits and await recall instructions from Illumina.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Illumina, Inc. or your healthcare provider for instructions. Notification method: Letter
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The NextSeq 550Dx is a high-throughput sequencing instrument used for sequencing DNA libraries in diagnostic workflows. The recall concerns reagent kits with flow cells that may leak due to gasket defects, risking run failures and exposure to hazardous substances.
Gasket defects in flow cells can cause leaks during sequencing. Leaks may lead to clogs in instrument fluidics, data loss and potential exposure to toxic materials.
This recall is not described as part of a broader industry pattern in the provided data.
Labs may experience halted runs and data gaps. Operators must halt use of affected kits and coordinate with Illumina for refunds or replacements. The recall could affect diagnostic workflows and scheduling.
Recall notices and identification information are provided by Illumina and available on the FDA enforcement page linked in the recall notice.
Refunds or replacements are generally processed within 4-8 weeks after initiating the recall.
Keep a copy of the recall letter, product labels, kit REF/Flow Cell REF, UDI-DI information, and all correspondence with Illumina.
- NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870 - NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871 - CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20064341 - CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064344 - CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD, REF: 20064345 - CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064346 - CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316 - CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530 - FLOWCELL, FIT FLUIDICS,
No injuries or incidents have been reported.
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