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[Recalled] Heavy Metals Test — Distribution without premarket approval/clearance | FDA 2025-11-03

recall fda device sweden

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

ProductHeavy Metals Test
Brand / manufacturerGET TESTED INTERNATIONAL AB
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0809-2026
Country of noticeSweden
Risk levelClass II
Hazard typerecall
Notice date03 November 2025
EAN / barcode616612785749

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Distribution without premarket approval/clearance.

This Class II recall concerns device products distributed in Sweden and was recorded by FDA_DEVICE. 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

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from GET TESTED INTERNATIONAL AB

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.

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