RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026VITROSOfficial source

    VITROS Chemistry Products recall in Canada: Inaccurate test results

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    In plain language

    This recall involves VITROS Chemistry Products 7% BSA and Urine Electrolyte Diluent (UED) sold in Canada. They are being recalled because they do not meet the specified on-analyzer stability time when stored in a 2ml cup on certain VITROS systems. This could lead to inaccurate test results.

    What to do

    • Stop using the affected products immediately.
    • Contact Ortho Clinical Diagnostics for more information.

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    Affected products

    • VITROS Chemistry Products 7% BSA

      Model: 8262487

      Lot: More than 10 numbers, contact manufacturer.

    • VITROS Chemistry Products Urine Electrolyte Diluent (UED)

      Model: 111 0352

      Lot: More than 10 numbers, contact manufacturer.

    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: More than 10 numbers, contact manufacturer.

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 111 0352, 8262487

    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 affected products immediately. Contact Ortho Clinical Diagnostics for more information.

    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 November 15, 2019.

    Is the VITROS brand affected by this recall?

    Yes, VITROS products are affected by this recall. This recall involves VITROS Chemistry Products 7% BSA and Urine Electrolyte Diluent (UED) sold in Canada. They are being recalled because they do not meet the specified on-analyzer stability time when stored in a 2ml cup on certain VITROS systems. This could lead to inaccurate test results.