Z-0794-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 10, 2025
- Initiation Date
- November 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
Peptic Ulcer Test (H, pylori)
Reason for Recall
Distribution without premarket approval/clearance.
Distribution Pattern
US Nationwide distribution.
Code Information
EAN: 616612787309; SKU: 2-B220; UDI-DI: None; Lot/Serial Number: All Lots;