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

    Beckman Coulter Au Immunochemistry System recall in Canada: labelling issue

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    In plain language

    This recall involves Beckman Coulter Au Immunochemistry Systems sold in Canada. It's being recalled because of an incorrect target value on the labelling for a calibrator. This recall is intended for healthcare professionals.

    What to do

    • Contact the manufacturer for additional information.

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    Affected products

    • Beckman Coulter Au Immunochemistry System - Apolipoprotein B

      Model: OSR6143

      Lot: 2631

    • Beckman Coulter Au2700 Immunochemistry System - Apolipoprotein B

      Model: OSR6143

      Lot: 2631

    • Beckman Coulter Au5400 Immunochemistry System- Apolipoprotein B Assay

      Model: OSR6143

      Lot: 2631

    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: 2631

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: OSR6143

    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?

    This recall involves Beckman Coulter Au Immunochemistry Systems sold in Canada. It's being recalled because of an incorrect target value on the labelling for a calibrator. This recall is intended for healthcare professionals.

    What should consumers do?

    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?

    A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.

    When was this product recalled?

    This product was recalled on May 7, 2025.

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

    Yes, BECKMAN COULTER, INC. products are affected by this recall. This recall involves Beckman Coulter Au Immunochemistry Systems sold in Canada. It's being recalled because of an incorrect target value on the labelling for a calibrator. This recall is intended for healthcare professionals.