GET TESTED INTERNATIONAL AB recalled 40 units of its Urinary Tract Infection Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately and follow the manufacturer's 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 Urinary Tract Infection Test is designed for at-home use to detect urinary tract infections. Consumers buy this product for convenience and quick results.
The lack of premarket approval/clearance means the product has not been evaluated for safety and effectiveness, posing potential health risks to users.
This recall is not part of a broader industry pattern.
Consumers may face inconvenience due to the recall and should seek alternative testing methods to ensure accurate diagnosis.
Check the product packaging for model numbers and any identifying information, including lot numbers.
Expect a response regarding refunds or replacements within 4-6 weeks.
Keep a record of your purchase, including receipts, and any correspondence related to the recall.
The recalled product is the Urinary Tract Infection Test, with model numbers EAN: 7340221700529 and SKU: A-URI. The product was distributed nationwide in the United States. No specific price was mentioned.
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