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    Medical devicesUpdated Jan 3, 2026RandoxOfficial source

    ASSAYED CHEMISTRY CONTROL PREMIUM PLUS recall in Canada: Inaccurate test results

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    In plain language

    This recall involves ASSAYED CHEMISTRY CONTROL PREMIUM PLUS, a medical device sold in Canada. It's being recalled because calibration targets were realigned, which could lead to inaccurate test results. Healthcare professionals should stop using affected products and follow the instructions from the manufacturer.

    What to do

    • Stop using the product immediately.
    • Check lot numbers 961UE and 995UE.
    • Contact Randox Laboratories Ltd. for updated control targets and instructions.

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    Affected products

    • ASSAYED CHEMISTRY CONTROL PREMIUM PLUS

      Model: CAL2351

      Lot: 961UE, 995UE

    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: 961UE, 995UE

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: CAL2351

    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 numbers 961UE and 995UE. Contact Randox Laboratories Ltd. for updated control targets and instructions.

    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 2, 2019.

    Is the Randox brand affected by this recall?

    Yes, Randox products are affected by this recall. This recall involves ASSAYED CHEMISTRY CONTROL PREMIUM PLUS, a medical device sold in Canada. It's being recalled because calibration targets were realigned, which could lead to inaccurate test results. Healthcare professionals should stop using affected products and follow the instructions from the manufacturer.