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

    Synchron® Systems Direct LDL Cholesterol (LDLD) Reagent

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    In plain language

    This recall involves Synchron Systems Direct LDL Cholesterol (LDLD) Reagent sold in Canada. It's being recalled because it may generate false high results. This medical device is intended for the healthcare industry.

    What to do

    • Contact the manufacturer for additional information.

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    Affected products

    • Synchron® Systems Direct LDL Cholesterol (LDLD) Reagent

      Model: 969706

      Lot: M404166

    Why this matters

    Performance issue leading to false high 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: M404166

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 969706

    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?

    Performance issue leading to false high results

    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?

    Yes, there may be a health risk. Performance issue leading to false high results

    When was this product recalled?

    This product was recalled on September 25, 2025.

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

    Yes, BECKMAN COULTER, INC. products are affected by this recall. This recall involves Synchron Systems Direct LDL Cholesterol (LDLD) Reagent sold in Canada. It's being recalled because it may generate false high results. This medical device is intended for the healthcare industry.