RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026BECKMAN COULTER, INC.Official source

    BECKMAN COULTER, INC. DxC 500i and DxI 9000 recall in Canada: performance issues

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    In plain language

    This recall involves DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer medical devices sold in Canada. They are being recalled because a software issue may prevent correct application of dilution factors, leading to inaccurate patient results. Healthcare professionals should contact the manufacturer for more information.

    What to do

    • Contact the manufacturer if you require additional information.

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    Affected products

    • DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module

      Model: C11137

      Lot: More than 10 numbers, contact manufacturer.

    • DxI 9000 Access Immunoassay Analyzer

      Model: C13252

      Lot: More than 10 numbers, contact manufacturer.

    Why this matters

    Inaccurate 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: C11137, C13252

    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.

    Want alerts if similar products are recalled in Canada?

    Frequently Asked Questions

    Why was this product recalled?

    Inaccurate test results

    What should consumers do?

    Contact the manufacturer if you require 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. Inaccurate test results

    When was this product recalled?

    This product was recalled on September 26, 2025.

    Is the BECKMAN COULTER, INC. brand affected by this recall?

    Yes, BECKMAN COULTER, INC. products are affected by this recall. This recall involves DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer medical devices sold in Canada. They are being recalled because a software issue may prevent correct application of dilution factors, leading to inaccurate patient results. Healthcare professionals should contact the manufacturer for more information.