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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GET TESTED INTERNATIONAL AB
- Product type
- Alcohol Test Kit
- Model numbers
- EAN: 7340221708884, SKU: A-ALC-S, UDI-DI: None, Lot/Serial Number: All Lots
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 3, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
December 17, 2025
Consumer action
Use the official remedy and keep documentation.
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
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
- Check the product packaging for the model number EAN: 7340221708884 or SKU: A-ALC-S.
- Verify if you purchased the Alcohol Test Saliva from GET TESTED INTERNATIONAL AB.
- 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.
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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
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Safety Guide
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