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.
Distribution without premarket approval/clearance.
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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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.
The product poses risks due to its distribution without premarket approval. This means it has not been evaluated for safety or accuracy.
This recall is not part of a broader industry pattern.
The recall may inconvenience consumers who rely on this device for alcohol testing, but it is essential for ensuring safety and compliance.
You can find the model number on the product packaging or the instruction manual.
Expect a refund or replacement to be processed within 4-6 weeks after returning the product.
Keep records of your purchase, including receipts and correspondence with the manufacturer.
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.
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