GET TESTED INTERNATIONAL AB recalled 528 syphilis tests distributed nationwide in the United States. The tests were distributed without premarket approval or clearance. Patients and healthcare providers should stop using them immediately and follow the manufacturer's 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 product is a syphilis diagnostic test kit intended for use in healthcare settings to screen for syphilis infections. It is distributed nationwide and used by clinicians to inform patient care decisions.
The defect involves distribution without premarket approval or clearance. This means the product may not have demonstrated safety or effectiveness to regulatory standards, potentially affecting test accuracy and patient care.
This recall is not described as part of a broader industry pattern in the notice.
Healthcare providers may need to halt use of the test and consult alternatives to avoid potential misdiagnosis and delayed treatment.
FDA enforceable recall page and official manufacturer communications
Refund or replacement processing commonly ranges from 4-8 weeks in recalls of this type
Keep copies of recall notices, packaging, model numbers, and all correspondence with the manufacturer
Brand: GET TESTED INTERNATIONAL AB; Product: Syphilis Test; Model numbers: EAN 7340221701656, SKU A-ISY; UDI-DI: None; Lot/Serial Number: All Lots; Sold nationwide in the United States; Recall date: 2025-11-03; Manufacturer: GET TESTED INTERNATIONAL AB; Price: Unknown; Quantity recalled: 528.
No injuries or incidents have been reported.
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