Get Tested International AB recalled 1,361 HSV-1 and HSV-2 Test Kits distributed nationwide in the United States after regulators found distribution without premarket approval. The test kit lacks FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall instructions by contacting Get Tested International AB.
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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HSV-1/HSV-2 tests diagnose herpes infections. Some kits are marketed for home or clinical use. The recall concerns regulatory clearance for this product.
Distribution without premarket approval suggests the device may not have been evaluated for safety and effectiveness by the FDA. The lack of clearance raises concerns about accuracy and reliability.
This recall is not identified as part of a broader industry pattern in the provided data.
Consumers may be using a test that lacks regulatory clearance, potentially leading to inaccurate results and inappropriate clinical decisions.
FDA recall page at the provided enforcement URL and manufacturer communications.
Refund or replacement, if offered, typically takes several weeks; expect 4-6 weeks for processing in many recalls.
Retain recall notice, packaging, purchase receipts, and all correspondence with the company.
Brand: Get Tested International AB Product: HSV-1 & HSV-2 Test Kit Model numbers: EAN 7340221710047, SKU A-HSV UDI-DI: None Lot/Serial Number: All Lots Quantity: 1361 units Sold in: United States nationwide distribution Sold by: Unknown Price: Unknown Date sold: Unknown
No injuries or incidents have been reported.
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