RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Official source

    Stratus CS Acute Care System Cardiac troponin-i TestPak (2019-06-04)

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    In plain language

    This recall involves the Stratus CS Acute Care System Cardiac troponin-i TestPak sold in Canada. It's being recalled because it may give false positive test results. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check lot numbers if provided.
    • Return or dispose of it as instructed.

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    Affected products

    • Stratus CS Acute Care System Cardiac troponin-i TestPak

      Model: CCTNI

      Lot: 238330002, 239007002, 239014002, 239028002, 239035002, 239056002, 239063002, 239070002, 239077002, 239105002, 239112002, 239119002

    Why this matters

    Inaccurate medical 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: 238330002, 239007002, 239014002, 239028002, 239035002, 239056002, 239063002, 239070002, 239077002, 239105002, 239112002, 239119002

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: CCTNI

    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 medical test results

    What should consumers do?

    Stop using the product immediately. Check lot numbers if provided. Return or dispose of it 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 medical test results

    When was this product recalled?

    This product was recalled on June 21, 2019.