GET TESTED INTERNATIONAL AB Recalls Urinary Tract Infection Test Due to Approval Issues
Distribution without premarket approval/clearance.
2,229 recalls tagged with “stop use immediately”.
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB recalled 29 Pet Allergy Test units on November 3, 2025. The recall follows distribution without premarket approval. Patients and healthcare providers must stop using the device immediately.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB recalled 18 units of Neurotransmitters Plus on November 3, 2025. The recall occurred due to distribution without premarket approval or clearance. Patients should cease use immediately and follow manufacturer instructions.
GET TESTED INTERNATIONAL AB recalled 71 units of its Allergy Test IgE on November 3, 2025. The recall follows distribution without premarket approval, classified as Class II. Patients and healthcare providers should stop using the device immediately.
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.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB's SIBO Test was distributed nationwide in the United States. The device was distributed without FDA premarket approval or clearance. Stop using the device immediately and follow the recall instructions from the manufacturer.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.