The Recall Desk
ModerateFDA (Food)·H-0228-2026·Announced 2025-12-10

Urinary tract infection tests recalled for lacking premarket approval or clearance

Get Tested International AB is recalling 40 units of its Urinary Tract Infection 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 Urinary Tract Infection Test from Get Tested International AB is being recalled. The product is identified by EAN 7340221700529 and SKU A-URI, 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 40 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
Dry Roasted Baking Macadamia Nuts, Unsalted Halves Ideal for Baking, Cooking, Salads or Ice Cream; NET WT 20 OZ (1 LB 4 OZ) 567g UPC: 8 60011 44301 8
Manufacturer
American Nuts, LLC
Category
Medical Device — Diagnostic test
Hazard
  • unapproved-device
  • premarket-clearance
  • regulatory

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 (1)

  • Lot Code: 307HMNC25L3

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category