RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026IMMAGEOfficial source

    IMMAGE Immunochemistry System IgM Immunoglobulin M Reagent recall in Canada

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    In plain language

    This recall involves the IMMAGE Immunochemistry System IgM Immunoglobulin M Reagent sold in Canada. It's being recalled because it may give incorrect test results for patient samples. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check the lot numbers M803185 and M806164.
    • Return the product as instructed.

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    Affected products

    • IMMAGE Immunochemistry System IgM Immunoglobulin M Reagent

      Model: 447610

      Lot: M803185, M806164

    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: M803185, M806164

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 447610

    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?

    This recall involves the IMMAGE Immunochemistry System IgM Immunoglobulin M Reagent sold in Canada. It's being recalled because it may give incorrect test results for patient samples. Stop using the product and follow the return steps in the official notice.

    What should consumers do?

    Stop using the product immediately. Check the lot numbers M803185 and M806164. 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?

    A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.

    When was this product recalled?

    This product was recalled on June 28, 2019.

    Is the IMMAGE brand affected by this recall?

    Yes, IMMAGE products are affected by this recall. This recall involves the IMMAGE Immunochemistry System IgM Immunoglobulin M Reagent sold in Canada. It's being recalled because it may give incorrect test results for patient samples. Stop using the product and follow the return steps in the official notice.