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    Medical devicesUpdated Jan 3, 2026ADVIA CentaurOfficial source

    ADVIA Centaur CKMB Assay recall in Canada: Inaccurate test results

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    In plain language

    This recall involves ADVIA Centaur and ADVIA Centaur CP System - Creatine Kinase-MB (CKMB) Assay sold in Canada. It's being recalled because of a bias in calibrator kits, which could lead to inaccurate test results. Stop using the affected products and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check lot numbers if provided.
    • Return the product as instructed.

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    Affected products

    • ADVIA Centaur System-Creatine Kinase-MB (CKMB) Assay

      Model: 9318028

      Lot: 57834A64, 57835A64, 72519A64, 98115A64

    • ADVIA Centaur CP System-Creatine Kinase-MB (CKMB) Assay

      Model: 9318028

      Lot: 57834A64, 57835A64, 72519A64, 98115A64

    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: 57834A64, 57835A64, 72519A64, 98115A64

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 9318028

    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 if provided. Return the product as instructed.

    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 17, 2018.

    Is the ADVIA Centaur brand affected by this recall?

    Yes, ADVIA Centaur products are affected by this recall. This recall involves ADVIA Centaur and ADVIA Centaur CP System - Creatine Kinase-MB (CKMB) Assay sold in Canada. It's being recalled because of a bias in calibrator kits, which could lead to inaccurate test results. Stop using the affected products and follow the return steps in the official notice.