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.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential Salmonella contamination."
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
- Affected units
- 2,700
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
Distributed in 1 state:
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