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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
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.
GET TESTED INTERNATIONAL AB recalled 19 Hair Mineral Analysis devices distributed nationwide in the United States. The recall cites distribution without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and contact GET TESTED INTERNATIONAL AB or their healthcare provider for instructions.
GET TESTED INTERNATIONAL AB recalled 33 units of its sperm test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled 109 units of its Candida Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers should stop using this device immediately.
GET TESTED INTERNATIONAL AB recalled 76 units of its Allergy Test on November 3, 2025. The recall occurred due to distribution without premarket approval. Patients and healthcare providers should stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled 94 units of its Parasite Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients should stop using the device immediately and follow provided instructions.
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.
GET TESTED INTERNATIONAL AB distributed 1 unit nationwide in the United States. The device lacked premarket approval or clearance. Stop using the product immediately and contact GET TESTED INTERNATIONAL AB for instructions.