RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Official source

    AQT90 FLEX Analyzers recall in Canada: data integrity problem

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    In plain language

    This recall involves AQT90 FLEX Analyzers with an e3800 PC unit installed, sold in Canada. It's being recalled because a data integrity problem can cause incorrect time stamps on test results. This could lead to errors in documentation and incorrect time intervals between measurements. Stop using the product and follow the return/repair steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check the model and serial numbers.
    • Contact Radiometer Medical Aps for further instructions.

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    Affected products

    • AQT90 FLEX Analyzers

      Model: 393-838

      Lot: 838R0571N013, 838R0571N014, 838R0571N016, 838R0571N018, 838R0571N019, 838R0571N020, 838R0571N021, 838R0571N023, 838R0571N024, 838R0572N012

    Why this matters

    Data integrity problem leading to 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: 838R0571N013, 838R0571N014, 838R0571N016, 838R0571N018, 838R0571N019, 838R0571N020, 838R0571N021, 838R0571N023, 838R0571N024, 838R0572N012

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 393-838

    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?

    Data integrity problem leading to incorrect test results

    What should consumers do?

    Stop using the product immediately. Check the model and serial numbers. Contact Radiometer Medical Aps 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. Data integrity problem leading to incorrect test results

    When was this product recalled?

    This product was recalled on December 24, 2020.