RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026BiomemeOfficial source

    Biomeme SARS-CoV-2 Real-Time RT-PCR Test recall in Canada: Unapproved software

    Share:

    In plain language

    This recall involves the Biomeme SARS-CoV-2 Real-Time RT-PCR Test sold in Canada. It's being recalled because an unapproved software version was shipped to a customer. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check the lot or serial number: Version 6.5.0 or 6.4.4.
    • Check the model number: 1000003.
    • Contact Biomeme Inc. for further instructions.

    Get alerts for recalls like this

    Get email alerts when new recalls affect products in this category.

    Categories (optional)

    No spam. Unsubscribe anytime. We only email when there's a relevant recall.

    Affected products

    • Biomeme SARS-CoV-2 Real-Time RT-PCR Test

      Model: 1000003

      Lot: Version 6.5.0, version 6.4.4

    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: Version 6.5.0, version 6.4.4

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 1000003

    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.

    Want alerts if similar products are recalled in Canada?

    Frequently Asked Questions

    Why was this product recalled?

    This recall involves the Biomeme SARS-CoV-2 Real-Time RT-PCR Test sold in Canada. It's being recalled because an unapproved software version was shipped to a customer. Stop using the product and follow the return steps in the official notice.

    What should consumers do?

    Stop using the product immediately. Check the lot or serial number: Version 6.5.0 or 6.4.4. Check the model number: 1000003. Contact Biomeme 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?

    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 October 8, 2021.

    Is the Biomeme brand affected by this recall?

    Yes, Biomeme products are affected by this recall. This recall involves the Biomeme SARS-CoV-2 Real-Time RT-PCR Test sold in Canada. It's being recalled because an unapproved software version was shipped to a customer. Stop using the product and follow the return steps in the official notice.