RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026AutostainerOfficial source

    Autostainer recall in Canada: May cause false test results

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    In plain language

    This recall involves Autostainer, Autostainer Plus, Autostainer Plus Link, and Autostainer 48 Link devices sold in Canada. They are being recalled because a leveling failure could impact staining quality, leading to false negative test results. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Contact the manufacturer for more information.
    • Follow the manufacturer's instructions for correction or return.

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    Affected products

    • Autostainer

      Model: S3400

      Lot: More than 10 numbers, contact manufacturer.

    • Autostainer Plus

      Model: S3800

      Lot: More than 10 numbers, contact manufacturer.

    • Autostainer Plus Link

      Model: AS100

      Lot: More than 10 numbers, contact manufacturer.

    • Autostainer 48 Link

      Model: AS480

      Lot: More than 10 numbers, contact manufacturer.

    Why this matters

    Risk of false negative 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: More than 10 numbers, contact manufacturer.

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: AS100, AS480, S3400, S3800

    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?

    Risk of false negative test results

    What should consumers do?

    Stop using the product immediately. Contact the manufacturer for more information. Follow the manufacturer's instructions for correction or return.

    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. Risk of false negative test results

    When was this product recalled?

    This product was recalled on May 3, 2019.

    Is the Autostainer brand affected by this recall?

    Yes, Autostainer products are affected by this recall. This recall involves Autostainer, Autostainer Plus, Autostainer Plus Link, and Autostainer 48 Link devices sold in Canada. They are being recalled because a leveling failure could impact staining quality, leading to false negative test results. Stop using the product and follow the return steps in the official notice.