RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026AtellicaOfficial source

    Atellica IM Analyzer recall in Canada: inaccurate test results

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    In plain language

    This recall involves Atellica IM 1300 and Atellica IM 1600 Analyzers sold in Canada. They are being recalled because they may produce inaccurate test results for samples with insufficient volume. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check model and serial numbers.
    • Contact Siemens Healthcare Diagnostics Inc. for further instructions.

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    Affected products

    • Atellica IM 1300 Analyzer

      Model: 11066001

      Lot: M00425 IM00882 IM00952 IM00987

    • Atellica IM 1600 Analyzer

      Model: 11066000

      Lot: IH00244 IH00255 IH00259

    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: IH00244 IH00255 IH00259, M00425 IM00882 IM00952 IM00987

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 11066000, 11066001

    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?

    Stop using the product immediately. Check model and serial numbers. Contact Siemens Healthcare Diagnostics Inc. for further 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. Inaccurate test results

    When was this product recalled?

    This product was recalled on September 24, 2021.

    Is the Atellica brand affected by this recall?

    Yes, Atellica products are affected by this recall. This recall involves Atellica IM 1300 and Atellica IM 1600 Analyzers sold in Canada. They are being recalled because they may produce inaccurate test results for samples with insufficient volume. Stop using the product and follow the return steps in the official notice.