Allergy IgE tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 71 units of its Allergy Test IgE 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 Allergy Test IgE from Get Tested International AB is being recalled. The product is identified by EAN 7340221707221 and SKU HT-IgE, 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 71 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
- Allergy Test IgE
- Manufacturer
- GET TESTED INTERNATIONAL AB
- Category
- Medical Device — Diagnostic test
- Affected units
- 71
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: 7340221707221
- SKU: HT-IgE
- 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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