RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026ORTHO-CLINICAL DIAGNOSTICS INC.Official source

    Ortho Optix™ Reader recall in Canada: Software defect

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    In plain language

    This recall involves the Ortho Optix™ Reader sold in Canada. It's being recalled because a software defect can cause incorrect quality control results. Stop using the product and contact the manufacturer for more information.

    What to do

    • Stop using the product immediately.
    • Contact the manufacturer for additional information.

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    Affected products

    • Ortho Optix™ Reader

      Model: 6842222

      Lot: Not applicable.

    Why this matters

    Incorrect quality control 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: Not applicable.

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 6842222

    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?

    Incorrect quality control results

    What should consumers do?

    Stop using the product immediately. Contact the manufacturer 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. Incorrect quality control results

    When was this product recalled?

    This product was recalled on April 19, 2022.

    Is the ORTHO-CLINICAL DIAGNOSTICS INC. brand affected by this recall?

    Yes, ORTHO-CLINICAL DIAGNOSTICS INC. products are affected by this recall. This recall involves the Ortho Optix™ Reader sold in Canada. It's being recalled because a software defect can cause incorrect quality control results. Stop using the product and contact the manufacturer for more information.