Z-0793-2026 Class II Ongoing

Recalled by GET TESTED INTERNATIONAL AB — Vastervik

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
94 units

Product Description

Parasite Test

Reason for Recall

Distribution without premarket approval/clearance.

Distribution Pattern

US Nationwide distribution.

Code Information

EAN: 616612786425; SKU: 2A178; UDI-DI: None; Lot/Serial Number: All Lots;