[pending] Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0735-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Distribution without premarket approval/clearance.
The recalled product
- Product
- Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
- Manufacturer
- GET TESTED INTERNATIONAL AB
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- EAN: 7340221708211
- SKU: A-EBV
- UDI-DI: None
- Lot/Serial Number: All Lots
Distribution
Distributed nationwide across the United States.
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