GET TESTED INTERNATIONAL AB: Device Recall
Recall #Z-0743-2026 · 11/03/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0743-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- GET TESTED INTERNATIONAL AB
- Status
- Ongoing
- Date Initiated
- 11/03/2025
- Location
- Vastervik, Sweden
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 940 units
Reason for Recall
Distribution without premarket approval/clearance.
Product Description
Lyme Test
Distribution Pattern
US Nationwide distribution.
Other Recalls by GET TESTED INTERNATIONAL AB
- Class II: Risk 11/03/2025
- Class II: Risk 11/03/2025
- Class II: Risk 11/03/2025
- Class II: Risk 11/03/2025
- Class II: Risk 11/03/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.