Epstein-Barr virus tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 4081 units of its Epstein-Barr Virus (EBV VCA & EBNA IgG) Test because the product was distributed without premarket approval or clearance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a premarket clearance shortfall with no stated product defect, consequence or reported harm.
Plain-English summary
The Epstein-Barr Virus (EBV VCA & EBNA IgG) Test from Get Tested International AB is being recalled. The product is identified by EAN 7340221708211 and SKU A-EBV, and the recall covers all lots.
The reason given in the enforcement record is distribution without premarket approval or clearance.
The record lists a quantity of 4081 units, distributed nationwide in the United States. The FDA has classified the action as Class II.
The record describes a regulatory clearance issue rather than a specific product defect, and states no injuries. Customers should follow the firm's instructions.
The recalled product
- Product
- Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
- Manufacturer
- GET TESTED INTERNATIONAL AB
- Category
- Medical Device — Diagnostic test
- Affected units
- 4,081
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.
Part of a larger recall action
This product is one of 92 recalled by GET TESTED INTERNATIONAL AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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