RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Abbott RealTime CMVOfficial source

    Abbott RealTime CMV recall in Canada: May cause inaccurate test results

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    In plain language

    This recall involves the Abbott RealTime CMV Control Kit (Lot Number 485936) sold in Canada. It's being recalled because it may show a higher than expected rate of error codes, which could lead to inaccurate test results. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check the lot number 485936.
    • Follow the instructions provided by Abbott Molecular Inc. for return or disposal.

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    Affected products

    • Abbott RealTime CMV Control Kit

      Model: 5N23-80

      Lot: 485936

    Why this matters

    May cause 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: 485936

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 5N23-80

    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?

    May cause inaccurate test results

    What should consumers do?

    Stop using the product immediately. Check the lot number 485936. Follow the instructions provided by Abbott Molecular Inc. for return or disposal.

    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. May cause inaccurate test results

    When was this product recalled?

    This product was recalled on April 29, 2019.

    Is the Abbott RealTime CMV brand affected by this recall?

    Yes, Abbott RealTime CMV products are affected by this recall. This recall involves the Abbott RealTime CMV Control Kit (Lot Number 485936) sold in Canada. It's being recalled because it may show a higher than expected rate of error codes, which could lead to inaccurate test results. Stop using the product and follow the return steps in the official notice.