FDAHealthNovember 3, 2025
GET TESTED INTERNATIONAL AB — Diabetes HbA1c Test
⚠️ 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
- Diabetes HbA1c Test
- Lot code
- /Serial
Additional details
EAN: 7340221707191; SKU: A-HbA1c; UDI-DI: None; Lot/Serial Number: All Lots;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 148 units.
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