[Recalled] Devyser AZF — Sale of unlicensed class III medical device in Canada | Health Canada 2017-01-18

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the Health Canada — Medical Devices notice, the identified hazard is: Sale of unlicensed class III medical device in Canada. Devyser AZF (8-A019) Kits were incorrectly labelled In Vitro Diagnostics (IVD) instead of Research Use Only (RUO).

This recall concerns Medical devices products distributed in Canada and was recorded by Health Canada — Medical Devices. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Review the official notice to confirm whether your unit is affected.

Read the full official notice →

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.