Illumina recalled 11,916 NextSeq 550Dx reagent kits on October 28, 2025. Flow cell gaskets in these kits may leak during DNA sequencing runs, risking toxic exposure to users. Healthcare providers must stop using these devices immediately and follow recall instructions.
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 recall involves multiple models of NextSeq 550Dx High Output and Mid Output Reagent Kits, including REF: 20028870 and REF: 20064345. These kits were distributed worldwide, including states such as PA, NJ, and CA. Price information is not provided.
The flow cell gaskets in the reagent kits have quality issues that may lead to leaks during operation. This can result in insufficient data output, instrument fluidics clogs, and exposure to toxic substances.
No specific incidents or injuries have been reported. The recall is classified as Class II, indicating a high hazard due to potential toxic exposure.
Stop using the reagent kits immediately. Contact Illumina, Inc. or your healthcare provider for instructions on returning the product. Notifications will be sent via letter.
For further details, call Illumina at 1-800-XXX-XXXX or visit their website at www.illumina.com. Additional information can be found at the FDA recall page.
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