RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Ortho-Clinical DiagnosticsOfficial source

    VITROS® ECi Immunodiagnostic System recall in Canada: Inaccurate test results

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    In plain language

    This recall involves VITROS® ECi Immunodiagnostic System - Troponin I Es Reagent Packs sold in Canada. It's being recalled because a manufacturing error could lead to inaccurate test results. Healthcare professionals should contact the manufacturer for more information.

    What to do

    • Contact the manufacturer if you require additional information.

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    Affected products

    • VITROS® ECi Immunodiagnostic System - Troponin I Es Reagent Pack

      Model: 680 2301, 680 2302

      Lot: 4800

    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: 4800

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 680 2301, 680 2302

    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?

    Contact the manufacturer if you require additional 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 June 22, 2023.

    Is the Ortho-Clinical Diagnostics brand affected by this recall?

    Yes, Ortho-Clinical Diagnostics products are affected by this recall. This recall involves VITROS® ECi Immunodiagnostic System - Troponin I Es Reagent Packs sold in Canada. It's being recalled because a manufacturing error could lead to inaccurate test results. Healthcare professionals should contact the manufacturer for more information.