RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026ZYMUTESTOfficial source

    ZYMUTEST HIA IgGAM MonoStrip recall in Canada: Typographical error

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    In plain language

    This recall involves ZYMUTEST HIA IgGAM MonoStrip medical devices sold in Canada. They are being recalled because of a typographical error in the instructions for use. Healthcare professionals should stop using the affected products and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check the lot numbers F1700416P1, F1701307P2, and F1701370P1.
    • Follow the instructions from Health Canada or HYPHEN BIOMED.

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    Affected products

    • ZYMUTEST HIA IgGAM MonoStrip

      Model: RK041D

      Lot: F1700416P1, F1701307P2, F1701370P1

    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: F1700416P1, F1701307P2, F1701370P1

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: RK041D

    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 ZYMUTEST HIA IgGAM MonoStrip medical devices sold in Canada. They are being recalled because of a typographical error in the instructions for use. Healthcare professionals should stop using the affected products and follow the return steps in the official notice.

    What should consumers do?

    Stop using the product immediately. Check the lot numbers F1700416P1, F1701307P2, and F1701370P1. Follow the instructions from Health Canada or HYPHEN BIOMED.

    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 March 23, 2018.

    Is the ZYMUTEST brand affected by this recall?

    Yes, ZYMUTEST products are affected by this recall. This recall involves ZYMUTEST HIA IgGAM MonoStrip medical devices sold in Canada. They are being recalled because of a typographical error in the instructions for use. Healthcare professionals should stop using the affected products and follow the return steps in the official notice.