Recall · FDA
GET TESTED INTERNATIONAL AB
GET TESTED INTERNATIONAL AB issued a Class II FDA recall (Z-0795-2026) initiated 2025-11-03: PSA Test
| Company | GET TESTED INTERNATIONAL AB |
|---|---|
| Recall number | Z-0795-2026 |
| Classification | Class II |
| Status | Ongoing |
| Category | Devices |
| Initiated | 2025-11-03 |
| Product | PSA Test |
| Reason | Distribution without premarket approval/clearance. |
FAQ
What did GET TESTED INTERNATIONAL AB recall?
PSA Test
Why was GET TESTED INTERNATIONAL AB's product recalled?
Distribution without premarket approval/clearance.