RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026SysmexOfficial source

    Sysmex XN-10 Hematology analyzer recall in Canada: Inaccurate results

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    In plain language

    This recall involves the Sysmex XN-10 Hematology analyzer sold in Canada. It's being recalled because it may provide inaccurate fluorescent platelet (PLT-F) results. Stop using the product and follow the return/repair steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check model/serial numbers if provided.
    • Return, repair, or dispose of it as instructed.

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    Affected products

    • Sysmex XN-10 Hematology analyzer

      Model: XN-10

      Lot: 35739

    Why this matters

    Inaccurate medical test results

    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: 35739

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: XN-10

    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?

    Inaccurate medical test results

    What should consumers do?

    Stop using the product immediately. Check model/serial numbers if provided. Return, repair, or dispose of it as instructed.

    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. Inaccurate medical test results

    When was this product recalled?

    This product was recalled on November 30, 2018.

    Is the Sysmex brand affected by this recall?

    Yes, Sysmex products are affected by this recall. This recall involves the Sysmex XN-10 Hematology analyzer sold in Canada. It's being recalled because it may provide inaccurate fluorescent platelet (PLT-F) results. Stop using the product and follow the return/repair steps in the official notice.