RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026LIFECODESOfficial source

    LIFECODES HLA Typing Kits recall in Canada: potential for incorrect test results

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    In plain language

    This recall involves LIFECODES HLA-DRB1 SSO, HLA-DQA1/B1 SSO, and HLA-DPA/B1 SSO Typing Kits sold in Canada. They are being recalled because an error in the software could lead to incorrect test results. Healthcare professionals should stop using the affected kits and follow the instructions in the official notice.

    What to do

    • Stop using the affected kits immediately.
    • Check the lot and model numbers of your kits.
    • Follow the instructions from Immucor regarding the affected products.

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    Affected products

    • LIFECODES HLA-DRB1 SSO TYPING KIT

      Model: 628923

      Lot: 04226A, 11125A

    • LIFECODES HLA-DQA1/B1 SSO TYPING KIT

      Model: 628930

      Lot: 06306A, 10205A, 3004970

    • LIFECODES HLA-DPA1/B1 SSO TYPING KIT

      Model: 628936

      Lot: 12085A, 3004756

    Why this matters

    Potential for incorrect 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: 04226A, 11125A, 06306A, 10205A, 3004970, 12085A, 3004756

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 628923, 628930, 628936

    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?

    Potential for incorrect test results

    What should consumers do?

    Stop using the affected kits immediately. Check the lot and model numbers of your kits. Follow the instructions from Immucor regarding the affected products.

    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. Potential for incorrect test results

    When was this product recalled?

    This product was recalled on March 23, 2018.

    Is the LIFECODES brand affected by this recall?

    Yes, LIFECODES products are affected by this recall. This recall involves LIFECODES HLA-DRB1 SSO, HLA-DQA1/B1 SSO, and HLA-DPA/B1 SSO Typing Kits sold in Canada. They are being recalled because an error in the software could lead to incorrect test results. Healthcare professionals should stop using the affected kits and follow the instructions in the official notice.