RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026ALINITY IOfficial source

    ALINITY I HIV AG/AB COMBO CALIBRATOR recall in Canada: Mislabelling issue

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    In plain language

    This recall involves the ALINITY I HIV AG/AB COMBO CALIBRATOR sold in Canada. It's being recalled because some vials were mislabeled, which can lead to invalid test results. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check the lot number 21292BE00.
    • Contact Abbott GmbH for return instructions.

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    Affected products

    • ALINITY I HIV AG/AB COMBO CALIBRATOR

      Model: 08P0701

      Lot: 21292BE00

    Why this matters

    Invalid test results due to mislabelling

    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: 21292BE00

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 08P0701

    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?

    Invalid test results due to mislabelling

    What should consumers do?

    Stop using the product immediately. Check the lot number 21292BE00. Contact Abbott GmbH for return instructions.

    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. Invalid test results due to mislabelling

    When was this product recalled?

    This product was recalled on February 19, 2021.

    Is the ALINITY I brand affected by this recall?

    Yes, ALINITY I products are affected by this recall. This recall involves the ALINITY I HIV AG/AB COMBO CALIBRATOR sold in Canada. It's being recalled because some vials were mislabeled, which can lead to invalid test results. Stop using the product and follow the return steps in the official notice.