GET TESTED INTERNATIONAL AB recalled 2,043 units of an 8 in 1 STI Test Kit sold nationwide in the United States. The recall is for distribution without premarket FDA approval or clearance. Consumers should stop using the device and follow the manufacturer’s recall instructions or contact the company for guidance.
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 product is an at-home diagnostic test kit marketed as an 8-in-1 STI test. It is distributed nationwide in the United States.
The recall concerns distribution without FDA premarket approval or clearance. This regulatory issue can affect test accuracy and consumer safety.
This recall is not part of a broader industry pattern.
Consumers may rely on test results that were not regulated for accuracy. There is potential for confusion and questions about liability, with no reported injuries in the notice.
Refer to FDA enforcement report Z-0818-2026 and the manufacturer communications for official guidance.
The recall notice does not specify a refund or replacement timeline.
Keep the recall notice, purchase receipts, product packaging, and all correspondence with the manufacturer as records.
Model numbers: EAN 7340221704794, SKU JD-8STI. UDI-DI: None. Lot/Serial Number: All Lots. Sold Nationwide in the United States. Quantity: 2,043 units.
No injuries or incidents have been reported.
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