RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Abbott GmbhOfficial source

    Alinity I Homocysteine Reagent Kit recall in Canada: Quality issue

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    In plain language

    This recall involves the Alinity I Homocysteine Reagent Kit sold in Canada. It's being recalled because some kits may produce suboptimal calibrations, affecting test results. Contact the manufacturer for more information.

    What to do

    • Contact the manufacturer if you require additional information.

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    Affected products

    • Alinity I Homocysteine Reagent Kit

      Model: 09P2820

      Lot: 11486UP00, 11466UP00, 11453UP00, 11485UP00, 11406UP00

    Why this matters

    Quality issue affecting 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: 11486UP00, 11466UP00, 11453UP00, 11485UP00, 11406UP00

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 09P2820

    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.

    Want alerts if similar products are recalled in Canada?

    Frequently Asked Questions

    Why was this product recalled?

    Quality issue affecting test results

    What should consumers do?

    Contact the manufacturer if you require 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. Quality issue affecting test results

    When was this product recalled?

    This product was recalled on April 4, 2022.

    Is the Abbott Gmbh brand affected by this recall?

    Yes, Abbott Gmbh products are affected by this recall. This recall involves the Alinity I Homocysteine Reagent Kit sold in Canada. It's being recalled because some kits may produce suboptimal calibrations, affecting test results. Contact the manufacturer for more information.