GET TESTED INTERNATIONAL AB's gonorrhea test was distributed nationwide in the United States. The recall cites distribution without FDA premarket approval or clearance. Patients and healthcare providers should stop using the test 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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A gonorrhea diagnostic test used to detect infection in clinical or point-of-care settings. Such tests guide treatment decisions if properly cleared and validated.
The recall centers on distribution without FDA premarket approval or clearance, raising regulatory and safety concerns about validation and clearance status.
This recall is not described as part of a broader industry pattern.
Immediate action is required to prevent use of potentially unregulated diagnostic tests and to avoid regulatory complications in clinical settings.
Refer to the FDA recall page for the product tabs with recall number Z-0738-2026.
If offered, refunds or replacements will follow manufacturer processing times, typically 4-8 weeks.
Keep the recall letter, product packaging, model numbers, and all correspondence with the manufacturer.
Model numbers: EAN 7340221701533; SKU: A-IGO; UDI-DI: None; Lot/Serial Number: All Lots. Where sold: US nationwide distribution. When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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