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    Medical devicesUpdated Jan 3, 2026Rotem ex-temOfficial source

    Rotem ex-tem recall in Canada: May cause inappropriate medical treatment

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    In plain language

    This recall involves Rotem ex-tem Thromboelastometry with Extrinsic Activation sold in Canada. It's being recalled because it may show prolonged clotting times, which could lead to patients receiving inappropriate medical treatment. 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 42255801.
    • Contact TEM Innovations GMBH for further instructions.

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    Affected products

    • Rotem ex-tem Thromboelastometry with Extrinsic Activation

      Model: 503-05-CA

      Lot: 42255801

    Why this matters

    Risk of inappropriate medical treatment

    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: 42255801

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 503-05-CA

    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?

    Risk of inappropriate medical treatment

    What should consumers do?

    Stop using the product immediately. Check the lot number 42255801. Contact TEM Innovations GMBH for further instructions.

    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. Risk of inappropriate medical treatment

    When was this product recalled?

    This product was recalled on August 2, 2019.

    Is the Rotem ex-tem brand affected by this recall?

    Yes, Rotem ex-tem products are affected by this recall. This recall involves Rotem ex-tem Thromboelastometry with Extrinsic Activation sold in Canada. It's being recalled because it may show prolonged clotting times, which could lead to patients receiving inappropriate medical treatment. Stop using the product and follow the return steps in the official notice.