RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026ORTHO-CLINICAL DIAGNOSTICS INC.Official source

    Vitros Chemistry Products HbA1c Reagent Kit recall in Canada: Performance issue

    Share:

    In plain language

    This recall involves the Vitros Chemistry Products HbA1c Reagent Kit sold in Canada. It's being recalled because of a performance issue that may lead to biased results. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Review the notice and perform required actions on any inventory.
    • Return the reply form.

    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

    Specific affected products are listed in the official notice.

    Why this matters

    Performance issue leading to biased results

    Do I have this product?

    This recall applies to specific products. Details are listed in the official notice.

    Want alerts if similar products are recalled in Canada?

    Frequently Asked Questions

    Why was this product recalled?

    Performance issue leading to biased results

    What should consumers do?

    Stop using the product immediately. Review the notice and perform required actions on any inventory. Return the reply form.

    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. Performance issue leading to biased results

    When was this product recalled?

    This product was recalled on April 26, 2023.

    Is the ORTHO-CLINICAL DIAGNOSTICS INC. brand affected by this recall?

    Yes, ORTHO-CLINICAL DIAGNOSTICS INC. products are affected by this recall. This recall involves the Vitros Chemistry Products HbA1c Reagent Kit sold in Canada. It's being recalled because of a performance issue that may lead to biased results. Stop using the product and follow the return steps in the official notice.