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

    VITROS® Systems recall in Canada: Performance issue

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    In plain language

    This recall involves VITROS® 4600, 5600, and 7600 Systems sold in Canada. They are being recalled because of a software anomaly that can affect how expired reagents are processed. Users should contact the manufacturer for additional information.

    What to do

    • Contact the manufacturer for additional information.

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    Affected products

    • VITROS® 4600 Chemistry System

      Model: 680 2445

    • VITROS® XT 7600 Integrated System

      Model: 6272222, 684 4461

    • VITROS® 5600 Integrated System

      Model: 680 2413, 680 2915

    • VITROS® 4600 Chemistry System - Refurbished

      Model: 690 0440

    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 model number

      Model numbers are typically on the product label or packaging.

      Affected models: 6272222, 680 2413, 680 2445, 680 2915, 684 4461, 690 0440

    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?

    This recall involves VITROS® 4600, 5600, and 7600 Systems sold in Canada. They are being recalled because of a software anomaly that can affect how expired reagents are processed. Users should contact the manufacturer for additional information.

    What should consumers do?

    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?

    A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.

    When was this product recalled?

    This product was recalled on June 5, 2025.

    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 VITROS® 4600, 5600, and 7600 Systems sold in Canada. They are being recalled because of a software anomaly that can affect how expired reagents are processed. Users should contact the manufacturer for additional information.