GET TESTED INTERNATIONAL AB recalled 94 units of its Parasite Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients should stop using the device immediately and follow provided instructions.
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 Parasite Test is a medical device used to detect parasitic infections. Consumers typically purchase these tests for home health monitoring or diagnostic purposes.
The lack of premarket approval means that the device has not undergone necessary regulatory evaluations to ensure its safety and efficacy for consumers.
This recall is not part of a broader industry pattern.
Consumers may face potential health risks by using an unapproved medical device. Immediate action is necessary to ensure safety.
Look for the EAN and SKU on the packaging or accompanying documentation.
Expect a refund or replacement process to take approximately 4-6 weeks.
Keep a copy of your purchase receipt and any correspondence with the manufacturer regarding the recall.
The Parasite Test was distributed nationwide in the United States. The recall affects all lots of the product with model numbers EAN: 616612786425, SKU: 2A178. The device was not approved for market distribution.
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