FDA Enforcement
Class II
Ongoing
2 in 1 Trichomonas / Gardnerella Test
Recall: Z-0816-2026
·
Reported December 10, 2025
Enforcement
- Recall Number
- Z-0816-2026
- Event ID
- 97896
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- GET TESTED INTERNATIONAL AB
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 10, 2025
- Initiation Date
- November 3, 2025
- Classification Date
- December 1, 2025
- Address
- 59334 Vastervik, Lysingsvagen 18, Vastervik, N/A, Sweden
Description
2 in 1 Trichomonas / Gardnerella Test
Reason
Distribution without premarket approval/clearance.
Code Info
EAN: 7340221700925; SKU: B-TOG; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution
US Nationwide distribution.
Quantity
754 units