RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Alere San Diego, Inc.Official source

    Cholestech Ldx Test recall in Canada: Inaccurate results

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    In plain language

    This recall involves Cholestech Ldx Total, HDL, Triglycerides Cholesterol and Glucose Tests sold in Canada. They are being recalled because the bilirubin interference level listed in the package insert is incorrect, which can impact the accuracy of triglyceride and HDL results. Healthcare professionals should contact the manufacturer for additional information.

    What to do

    • Contact the manufacturer if you require additional information.

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    Affected products

    • Cholestech Ldx Total Cholesterol Test

      Model: 10-987, 10-989, 10-990, 10-991

      Lot: All lots

    • Cholestech Ldx Hdl Cholesterol Test

      Model: 10-987, 10-989, 10-990, 10-991

      Lot: All lots

    • Cholestech Ldx Triglycerides Test

      Model: 10-989, 10-991

      Lot: All lots

    • Cholestech Ldx Glucose Test

      Model: 10-990, 10-991

      Lot: All lots

    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: All lots

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 10-987, 10-989, 10-990, 10-991

    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?

    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 June 20, 2022.

    Is the Alere San Diego, Inc. brand affected by this recall?

    Yes, Alere San Diego, Inc. products are affected by this recall. This recall involves Cholestech Ldx Total, HDL, Triglycerides Cholesterol and Glucose Tests sold in Canada. They are being recalled because the bilirubin interference level listed in the package insert is incorrect, which can impact the accuracy of triglyceride and HDL results. Healthcare professionals should contact the manufacturer for additional information.