RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026VITROSOfficial source

    VITROS 5600 Integrated System recall in Canada: incorrect test results

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    In plain language

    This recall involves the VITROS 5600 Integrated System used in healthcare settings in Canada. It's being recalled because a part of the system may not dispense the correct sample volume, which could lead to incorrect test results. Healthcare professionals should follow the instructions in the official notice.

    What to do

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

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    Affected products

    • VITROS 5600 Integrated System

      Model: 6802413

      Lot: More than 10 numbers, contact manufacturer.

    Why this matters

    Incorrect 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: 6802413

    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?

    Incorrect test results

    What should consumers do?

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

    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 test results

    When was this product recalled?

    This product was recalled on August 31, 2018.

    Is the VITROS brand affected by this recall?

    Yes, VITROS products are affected by this recall. This recall involves the VITROS 5600 Integrated System used in healthcare settings in Canada. It's being recalled because a part of the system may not dispense the correct sample volume, which could lead to incorrect test results. Healthcare professionals should follow the instructions in the official notice.