GET TESTED INTERNATIONAL AB recalled 12 serotonin test devices distributed nationwide in the United States after the device was distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall instructions. Contact GET TESTED INTERNATIONAL AB for instructions or consult your healthcare provider.
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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Serotonin tests measure serotonin levels for diagnostic or research purposes. They are used by healthcare providers in clinical settings.
The device was distributed without required premarket approval or clearance, which may affect regulatory safety compliance for clinical use.
This recall is not described as part of a broader industry pattern.
No injuries reported. Affects 12 units; requires immediate cessation of use and adherence to manufacturer instructions.
Recall notification letters or the manufacturer’s guidance; FDA recall page for Z-0815-2026.
Not specified by the manufacturer. Expect further instructions from GET TESTED INTERNATIONAL AB.
Keep the recall letter, packaging, and purchase details. Save all correspondence with the manufacturer.
Model numbers: EAN 616612785718; SKU 1SE; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the United States. Recall date: 2025-11-03. Manufacturer: GET TESTED INTERNATIONAL AB. Categories: Health & Personal Care; Medical Devices. Quantity recalled: 12 units. Price: Unknown.
No injuries or incidents have been reported.
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