FDAFDA · Food and drugs·Recall number Z-0795-2026
PSA Test
Published December 10, 2025 · Recall initiated: November 3, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Distribution without premarket approval/clearance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GET TESTED INTERNATIONAL AB
- Distributor
- US Nationwide distribution.
- Lot
- EAN: 616612787316; SKU: G670D; UDI-DI: None; Lot/Serial Number: All Lots;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
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