FDAHealthNovember 3, 2025
GET TESTED INTERNATIONAL AB — Lyme 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
- Lyme Test
- Lot code
- /Serial
Additional details
EAN: 7340221700468; SKU: A-ILY; UDI-DI: None; Lot/Serial Number: All Lots;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 940 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.