RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026VYSISOfficial source

    VYSIS CLL FISH PROBE KIT recall in Canada: Inaccurate test results

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    In plain language

    This recall involves the VYSIS CLL FISH PROBE KIT sold in Canada. It's being recalled because it may not accurately detect certain genetic deletions in patient samples. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check lot and model numbers.
    • Return or dispose of it as instructed.

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    Affected products

    • VYSIS CLL FISH PROBE KIT

      Model: 04N02-021

      Lot: 517086, 518656

    Why this matters

    Inaccurate 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: 517086, 518656

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 04N02-021

    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 test results

    What should consumers do?

    Stop using the product immediately. Check lot and model numbers. Return 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 test results

    When was this product recalled?

    This product was recalled on August 27, 2021.

    Is the VYSIS brand affected by this recall?

    Yes, VYSIS products are affected by this recall. This recall involves the VYSIS CLL FISH PROBE KIT sold in Canada. It's being recalled because it may not accurately detect certain genetic deletions in patient samples. Stop using the product and follow the return steps in the official notice.