Z-0741-2026 Class II Ongoing
FDA device recall Z-0741-2026 was initiated by GET TESTED INTERNATIONAL AB on Nov 3, 2025 and is designated Class II. Reason for recall: Distribution without premarket approval/clearance. The recall status is ongoing. Affected quantity: 258 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 10, 2025
- Initiation Date
- Nov 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 258 units
Product Description
HPV Antigen Test
Reason for Recall
Distribution without premarket approval/clearance.
Distribution Pattern
US Nationwide distribution.
Code Information
EAN: 7340221708259; SKU: A-HPV; UDI-DI: None; Lot/Serial Number: All Lots;