RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026RandoxOfficial source

    Urinalysis Control Level 2 recall in Canada: Inaccurate test results

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    In plain language

    This recall involves Urinalysis Control Level 2 sold in Canada. It's being recalled because the analyte range for leukocytes needs to be re-assigned for use with the Siemens Multistix method. Updated value sheets are now available online.

    What to do

    • Stop using the product immediately.
    • Check model/serial numbers if provided.
    • Refer to the official notice for updated value sheets.

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    Affected products

    • Urinalysis Control Level 2

      Model: UC5034

      Lot: 1020UC

    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: 1020UC

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: UC5034

    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 model/serial numbers if provided. Refer to the official notice for updated value sheets.

    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 9, 2019.

    Is the Randox brand affected by this recall?

    Yes, Randox products are affected by this recall. This recall involves Urinalysis Control Level 2 sold in Canada. It's being recalled because the analyte range for leukocytes needs to be re-assigned for use with the Siemens Multistix method. Updated value sheets are now available online.