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

    Vitros ECi Immunodiagnostic Intact PTH Reagent

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    In plain language

    This recall involves Vitros ECi Immunodiagnostic Intact PTH Reagent sold in Canada. It's being recalled because of a performance issue that may lead to inaccurate test results. Stop using the product and contact the manufacturer for more information.

    What to do

    • Stop using the product immediately.
    • Contact Ortho-Clinical Diagnostics for additional information.

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    Affected products

    • Vitros ECi Immunodiagnostic Intact PTH Reagent

      Lot: 1610, 1621, 1640, 1650, 1645, 1630, 1670, 680, 2892

    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: 1610, 1621, 1640, 1650, 1645, 1630, 1670, 680, 2892

    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. Contact Ortho-Clinical Diagnostics for 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 December 2, 2022.

    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 Intact PTH Reagent sold in Canada. It's being recalled because of a performance issue that may lead to inaccurate test results. Stop using the product and contact the manufacturer for more information.