FDA recall Z-0804-2026
GET TESTED INTERNATIONAL AB · Class II · device
Product
Allergy test Small
Reason for recall
Distribution without premarket approval/clearance.
Distribution
US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-11-03
- Report date
- 2025-12-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Vastervik, Sweden
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0804-2026