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    Medical devicesUpdated Jan 3, 2026Diasorin Inc.Official source

    Biotrin Parvovirus B19 IgM recall in Canada: Performance issues

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    In plain language

    This recall involves Biotrin Parvovirus B19 IgM, a medical device used for testing, sold in Canada. It's being recalled because it may cause invalid test results, including false negatives. Healthcare professionals should contact the manufacturer for more information.

    What to do

    • Contact the manufacturer, Diasorin Inc., if you require additional information.

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    Affected products

    • Biotrin Parvovirus B19 IgM

      Model: 317080

      Lot: 157063

    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: 157063

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 317080

    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?

    This recall involves Biotrin Parvovirus B19 IgM, a medical device used for testing, sold in Canada. It's being recalled because it may cause invalid test results, including false negatives. Healthcare professionals should contact the manufacturer for more information.

    What should consumers do?

    Contact the manufacturer, Diasorin Inc., 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?

    A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.

    When was this product recalled?

    This product was recalled on June 20, 2025.

    Is the Diasorin Inc. brand affected by this recall?

    Yes, Diasorin Inc. products are affected by this recall. This recall involves Biotrin Parvovirus B19 IgM, a medical device used for testing, sold in Canada. It's being recalled because it may cause invalid test results, including false negatives. Healthcare professionals should contact the manufacturer for more information.