FDAHealthNovember 3, 2025
GET TESTED INTERNATIONAL AB — Peptic Ulcer Test (H, pylori)
⚠️ Distribution without premarket approval/clearance.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 3, 2025
US Nationwide distribution.
What's affected?
- Product
- Peptic Ulcer Test (H, pylori)
- Lot code
- /Serial
Additional details
EAN: 616612787309; SKU: 2-B220; UDI-DI: None; Lot/Serial Number: All Lots;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 12 units.
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