RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026AlinityOfficial source

    Alinity c Processing Module recall in Canada: may cause inaccurate test results

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    In plain language

    This recall involves the Alinity c Processing Module sold in Canada. It's being recalled because individual cuvettes may become seated too low, leading to inaccurate patient test results. Stop using the product and follow the return/repair steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Contact the manufacturer for instructions.
    • Check model/serial numbers if provided.

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    Affected products

    • Alinity c Processing Module

      Model: 03R67-01

      Lot: More than 10 numbers, contact manufacturer.

    Why this matters

    Inaccurate 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: More than 10 numbers, contact manufacturer.

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 03R67-01

    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?

    Inaccurate test results

    What should consumers do?

    Stop using the product immediately. Contact the manufacturer for instructions. Check model/serial numbers if provided.

    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. Inaccurate test results

    When was this product recalled?

    This product was recalled on May 10, 2019.

    Is the Alinity brand affected by this recall?

    Yes, Alinity products are affected by this recall. This recall involves the Alinity c Processing Module sold in Canada. It's being recalled because individual cuvettes may become seated too low, leading to inaccurate patient test results. Stop using the product and follow the return/repair steps in the official notice.