RecallGuide.ca
    Medical devices••Updated Jan 3, 2026•Diamed Gmbh•Official source

    IH-500 recall in Canada: Medical device performance issue

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    In plain language

    This recall involves the IH-500 medical device and related Diaclon products sold in Canada. It's being recalled because of a performance issue where the device may not properly detect dispense failures. Healthcare professionals should contact BIO-RAD LABORATORIES (CANADA) LTD. for more information.

    What to do

    • Stop using the product immediately.
    • Contact BIO-RAD LABORATORIES (CANADA) LTD. for additional information.

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    Affected products

    • IH-500

      Model: 001500

      Lot: All lots

    • Diaclon Abo/D+Reverse-Group

      Model: 001234, 001235, 001236, 001237

      Lot: All lots

    • Diaclon Anti-N

      Model: 00711

      Lot: All lots

    • Diaclon Abd Confirmation For Donors

      Model: 001133, 001134, 001135, 001136

      Lot: All lots

    • Diaclon Rh-Subgroup+K

      Model: 002124, 002125, 002126, 002127

      Lot: All lots

    • Diaclon Anti-M

      Model: 007011

      Lot: All lots

    • Diaclon Abd Confirmation For Patients

      Model: 001254, 001255, 001256, 001257

      Lot: All lots

    Why this matters

    Medical device performance issue

    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: All lots

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 001133, 001134, 001135, 001136, 001234, 001235, 001236, 001237, 001254, 001255, 001256, 001257, 001500, 002124, 002125, 002126, 002127, 007011, 00711

    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?

    Medical device performance issue

    What should consumers do?

    Stop using the product immediately. Contact BIO-RAD LABORATORIES (CANADA) LTD. for 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. Medical device performance issue

    When was this product recalled?

    This product was recalled on October 13, 2022.

    Is the Diamed Gmbh brand affected by this recall?

    Yes, Diamed Gmbh products are affected by this recall. This recall involves the IH-500 medical device and related Diaclon products sold in Canada. It's being recalled because of a performance issue where the device may not properly detect dispense failures. Healthcare professionals should contact BIO-RAD LABORATORIES (CANADA) LTD. for more information.