RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Official source

    Homocysteine Calibrator recall in Canada: May cause false test results

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    In plain language

    This recall involves the Homocysteine Calibrator kit sold in Canada. It's being recalled because it may cause inaccurate test results. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check the model and lot numbers.
    • Contact Roche Diagnostics GMBH for return instructions.

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    Affected products

    • HOMOCYSTEINE CALIBRATOR

      Model: 5385504190

      Lot: 235108

    Why this matters

    False 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: 235108

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 5385504190

    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?

    False test results

    What should consumers do?

    Stop using the product immediately. Check the model and lot numbers. Contact Roche Diagnostics GMBH for return 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. False test results

    When was this product recalled?

    This product was recalled on March 13, 2018.