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    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, model 6842222, sold in Canada. It's being recalled because of a software defect that affects how it reads card lot numbers. Stop using the product and contact the manufacturer for more information.

    What to do

    • Stop using the product immediately.
    • Check the model number 6842222 and software version 1.0.1.3077 and below.
    • Contact the manufacturer for additional information.

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    Affected products

    • ORTHO OPTIX READER

      Model: 6842222

      Lot: Software 1.0.1.3077 and below

    Why this matters

    Software defect

    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: Software 1.0.1.3077 and below

    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.

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    Frequently Asked Questions

    Why was this product recalled?

    Software defect

    What should consumers do?

    Stop using the product immediately. Check the model number 6842222 and software version 1.0.1.3077 and below. 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. Software defect

    When was this product recalled?

    This product was recalled on December 2, 2021.

    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, model 6842222, sold in Canada. It's being recalled because of a software defect that affects how it reads card lot numbers. Stop using the product and contact the manufacturer for more information.