Get Tested International AB recalled 1,210 units of its 3 in 1 STI Test distributed nationwide in the U.S. The product was distributed without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall 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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This is a at-home diagnostic test marketed as a 3-in-1 STI test kit. Consumers purchase it for quick screening for multiple sexually transmitted infections.
The hazard arises from distributing a diagnostic device without proper regulatory clearance. The device may not have been evaluated for safety and effectiveness.
This recall is not described as part of a broader industry pattern in the provided information.
Consumers may experience delays in obtaining regulated testing or may seek alternative testing options until proper clearance is secured.
Recall notices and model identifiers are typically listed on the packaging, the manufacturer’s site, and the FDA recall page.
Refund or replacement processing often takes several weeks; exact timelines are provided by the manufacturer.
Save purchase receipts, recall notices, and all correspondence with the manufacturer. Take photos of the product packaging and serial numbers.
Brand: Get Tested International AB Product: 3 in 1 STI Test Model numbers: EAN 7340221704770; SKU JD-3STI; UDI-DI: None; Lot/Serial Number: All Lots Sold nationwide in the United States Quantity recalled: 1,210 units Recall date: 2025-11-03 Status: ACTIVE Category: Health & Personal Care, Medical Devices
No injuries or incidents have been reported.
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