HIGH

GET TESTED INTERNATIONAL AB Issues Recall of Alcohol Test Kit

GET TESTED INTERNATIONAL AB recalled one unit of its Alcohol Test Saliva on November 3, 2025, due to distribution without premarket approval. The recall affects the entire lot of this medical device. Consumers and healthcare providers must stop using the device immediately.

Quick Facts at a Glance

Recall Date
November 3, 2025
Hazard Level
HIGH
Brand
GET TESTED INTERNATIONAL AB
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Distribution without premarket approval/clearance.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Alcohol Test Saliva is a medical device used to determine the presence of alcohol in saliva. Consumers purchase it for personal or professional use to assess alcohol levels.

Why This Is Dangerous

The product poses risks due to its distribution without premarket approval. This means it has not been evaluated for safety or accuracy.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall may inconvenience consumers who rely on this device for alcohol testing, but it is essential for ensuring safety and compliance.

Practical Guidance

How to identify if yours is affected

  1. Check the product packaging for the model number EAN: 7340221708884 or SKU: A-ALC-S.
  2. Verify if you purchased the Alcohol Test Saliva from GET TESTED INTERNATIONAL AB.
  3. Confirm that your kit is part of the recall by comparing it with the recalled product description.

Where to find product info

You can find the model number on the product packaging or the instruction manual.

What timeline to expect

Expect a refund or replacement to be processed within 4-6 weeks after returning the product.

If the manufacturer is unresponsive

  • Contact GET TESTED INTERNATIONAL AB again for follow-up.
  • File a complaint with the FDA if the company does not respond.

How to prevent similar issues

  • Only purchase medical devices that have been approved by the FDA.
  • Check for FDA clearance on medical devices before use.
  • Consult professionals for recommendations on reliable alcohol test kits.

Documentation advice

Keep records of your purchase, including receipts and correspondence with the manufacturer.

Product Details

The recalled product is Alcohol (ALC) Test Saliva. The recall involves one unit with the model numbers EAN: 7340221708884 and SKU: A-ALC-S. The product was distributed nationwide in the U.S.

Key Facts

  • Class II medical device
  • Recall date: November 3, 2025
  • Distribution: US nationwide
  • Stop using immediately

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
EAN: 7340221708884
SKU: A-ALC-S
UDI-DI: None
Lot/Serial Number: All Lots
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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