RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Diagnostica Stago SasOfficial source

    Asserachrom® HPIA recall in Canada: Performance issue

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    In plain language

    This recall involves Asserachrom® HPIA, a medical device, sold in Canada. It's being recalled because approximately 5% of reagent 1 strips may have a defect, leading to inaccurate test results. Stop using the product and follow the return/disposal steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check the lot number: 271288.
    • Dispose of all remaining product according to local regulations.
    • Contact the manufacturer if you require additional information.

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    Affected products

    • Asserachrom® HPIA

      Model: 00615

      Lot: 271288

    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: 271288

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 00615

    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 the lot number: 271288. Dispose of all remaining product according to local regulations. Contact the manufacturer if you require 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 23, 2025.

    Is the Diagnostica Stago Sas brand affected by this recall?

    Yes, Diagnostica Stago Sas products are affected by this recall. This recall involves Asserachrom® HPIA, a medical device, sold in Canada. It's being recalled because approximately 5% of reagent 1 strips may have a defect, leading to inaccurate test results. Stop using the product and follow the return/disposal steps in the official notice.