RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Official source

    Cobas Pro ISE Analytical Unit recall in Canada: erroneous results

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    In plain language

    This recall involves the Cobas Pro ISE Analytical Unit. It's being recalled because a quality issue could lead to erroneous results without an alert. No customers in Canada are impacted as the single affected unit was not distributed.

    What to do

    • Stop using the product immediately.
    • Check model/serial numbers if provided.
    • Return, repair, or dispose of it as instructed.

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    Affected products

    • Cobas Pro ISE Analytical Unit

      Model: 8468537001

      Lot: 1909-04-01

    Why this matters

    Erroneous results without data flag or system alarm

    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: 1909-04-01

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 8468537001

    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?

    Erroneous results without data flag or system alarm

    What should consumers do?

    Stop using the product immediately. Check model/serial numbers if provided. Return, repair, or dispose of it as instructed.

    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. Erroneous results without data flag or system alarm

    When was this product recalled?

    This product was recalled on August 23, 2019.