Medical devicesUpdated Jan 3, 2026VITROS® SystemsOfficial source

    VITROS® Systems recall in Canada: Performance issues

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    In plain language

    This recall involves VITROS® Systems sold in Canada. They are being recalled because of performance issues with the software. Stop using the product and contact the manufacturer for more information.

    What to do

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

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    Affected products

    • VITROS® 3600 Immunodiagnostic System-Instrument Software Version 3.8.0 and 3.8

      Lot: 680 2914, 680 2783

    • VITROS® XT 7600 Integrated System Software Version 3.8.0 and 3.8

      Lot: 684 4461

    • VITROS® 4600 Chemistry System - Hardware Software Version 3.8.0 and 3.8

      Lot: 680 2445, 690 0440

    • VITROS® 4600 Chemistry System - Refurbished Hardware Software Version 3.8.0 and 3.8

      Lot: 690 0440

    • VITROS® 5600 Integrated System Software Version 3.8.0 and 3.8

      Lot: 680 2413, 680 2915

    • VITROS® XT 3400 Chemistry System Software Version 3.8.0 and 3.8

      Lot: 684 4458

    Why this matters

    Performance issues

    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: 680 2413, 680 2915, 680 2445, 690 0440, 680 2914, 680 2783, 684 4458, 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?

    Performance issues

    What should consumers do?

    Stop using the product immediately. Check the model and software version. 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. Performance issues

    When was this product recalled?

    This product was recalled on February 9, 2024.

    Is the VITROS® Systems brand affected by this recall?

    Yes, VITROS® Systems products are affected by this recall. This recall involves VITROS® Systems sold in Canada. They are being recalled because of performance issues with the software. Stop using the product and contact the manufacturer for more information.