[Recalled] Mycoplasma test, IgG and IgM — Distribution without premarket approval/clearance | FDA 2025-11-03
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Mycoplasma test, IgG and IgM |
|---|---|
| Brand / manufacturer | GET TESTED INTERNATIONAL AB |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0746-2026 |
| Country of notice | Sweden |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 03 November 2025 |
| EAN / barcode | 7340221710030 |
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.