Medical devicesUpdated Jan 3, 2026Illumina, Inc.Official source

    NextSeq™ 550Dx and MiSeq™Dx Instruments recall in Canada: performance issue

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    In plain language

    This recall involves NextSeq™ 550Dx and MiSeq™Dx Instruments sold in Canada. They are being recalled because of a security vulnerability that could affect performance. Healthcare professionals should follow the instructions provided by the manufacturer.

    What to do

    • Stop using the product immediately.
    • Check the model and serial numbers.
    • Follow the instructions provided by the manufacturer to correct the situation.

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    Affected products

    • MiSeq™Dx Instrument

      Model: DX-410-1001

      Lot: M70286-15037414, M70292-15037414, M70335-15037414, M70553-15037414, M70546-15037414, M70293-15037414, M70444-15037414, M70349-15037414, M70552-15037414, M70440-15037414, M71207-20014737

    • NextSeq™ 550Dx Instrument

      Model: 20005715

      Lot: NDX551031-15073937, NDX551020-15073937, NDX551316-15073937

    Why this matters

    Performance issue

    Do I have this product?

    This recall only applies to specific products. Follow the steps below to check.

    1. 1

      Check the product name

      Make sure your product name matches one of the affected products listed above.

    2. 2

      Check the lot number

      Lot numbers identify specific production batches.

      Affected lots: M70286-15037414, M70292-15037414, M70335-15037414, M70553-15037414, M70546-15037414, M70293-15037414, M70444-15037414, M70349-15037414, M70552-15037414, M70440-15037414, M71207-20014737, NDX551031-15073937, NDX551020-15073937, NDX551316-15073937

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 20005715, DX-410-1001

    If your product matches one or more of the details above, it may be affected by this recall.

    If your product does not match these details, it is not affected by this recall.

    When in doubt, always check the official notice.

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    Frequently Asked Questions

    Why was this product recalled?

    Performance issue

    What should consumers do?

    Stop using the product immediately. Check the model and serial numbers. Follow the instructions provided by the manufacturer to correct the situation.

    Where was the product sold?

    This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.

    Is there a health risk?

    Yes, there may be a health risk. Performance issue

    When was this product recalled?

    This product was recalled on July 5, 2024.

    Is the Illumina, Inc. brand affected by this recall?

    Yes, Illumina, Inc. products are affected by this recall. This recall involves NextSeq™ 550Dx and MiSeq™Dx Instruments sold in Canada. They are being recalled because of a security vulnerability that could affect performance. Healthcare professionals should follow the instructions provided by the manufacturer.