68 recalls found for Get Tested International AB. Check if any of your products are affected.
Get Tested International AB recalled 1,210 units of its 3 in 1 STI Test distributed nationwide in the U.S. The product was distributed without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall instructions.,
GET TESTED INTERNATIONAL AB's Lyme Test devices were distributed nationwide in the United States to healthcare providers. Regulators found the devices were distributed without FDA premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow recall instructions.
GET TESTED INTERNATIONAL AB recalled 5 chlamydia test devices distributed nationwide in the United States after regulators found distribution without FDA premarket approval or clearance. The devices lack required premarket authorization. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall instructions.
GET TESTED INTERNATIONAL AB recalled 3 Food Sensitivity Test Small units distributed nationwide in the United States after a lack of premarket approval was identified. The recall is classified as Class II with a high-level hazard. Consumers should stop using the product immediately and follow the recall instructions from the manufacturer.
GET TESTED INTERNATIONAL AB recalled 658 parasite tests distributed nationwide in the United States after regulators flagged distribution without premarket approval. The recall, active as of December 2025, targets devices labeled EAN 7340221707153 and SKU A-PARA. Healthcare providers and patients should stop using the device immediately and follow manufacturer recall instructions.
GET TESTED INTERNATIONAL AB recalled 1,916 Thyroid TSH Tests distributed nationwide in the United States. The devices were distributed without premarket approval or clearance. Healthcare providers and patients should stop using the tests and follow manufacturer instructions immediately.
GET TESTED INTERNATIONAL AB recalled 17 DHEA Test devices distributed nationwide in the United States after regulators flagged distribution without premarket approval. The devices lack FDA Premarket Approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall instructions.
GET TESTED INTERNATIONAL AB recalled 166 units of its Candida Test distributed nationwide in the United States. The device was distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall instructions from the manufacturer.
GET TESTED INTERNATIONAL AB recalled 19 Allergy Test Small devices distributed nationwide in the United States after distribution without premarket approval or clearance. The devices were distributed without FDA clearance. Patients and healthcare providers should stop using this device immediately and contact GET TESTED INTERNATIONAL AB for instructions.
GET TESTED INTERNATIONAL AB recalled 5 units of its Food Intolerance Test Small on November 3, 2025. The recall follows the distribution of the device without necessary premarket approval. Healthcare providers and patients must cease use immediately and follow the manufacturer's instructions.
GET TESTED INTERNATIONAL AB recalled one unit of its Organic Acids Profile Test Large on November 3, 2025. The recall occurred due to distribution without necessary premarket approval. Patients and healthcare providers should stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled one medical device on November 3, 2025, due to distribution without premarket approval. The recall affects the entire lot and requires immediate cessation of use. Patients and healthcare providers must follow the manufacturer’s instructions for safe disposal or return of the product.
GET TESTED INTERNATIONAL AB recalled 17 units of its Adrenal Test on November 3, 2025. The recall occurred due to distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled 258 HPV Antigen Tests on November 3, 2025. The tests were distributed nationwide without premarket approval or clearance. Healthcare providers and patients must stop using these devices immediately.
GET TESTED INTERNATIONAL AB recalled one unit of its Alcohol Test Saliva on November 3, 2025, due to distribution without premarket approval. The recall affects the entire lot of this medical device. Consumers and healthcare providers must stop using the device immediately.
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.
GET TESTED INTERNATIONAL AB recalled a single Sperm Test device distributed nationwide in the United States on 2025-11-03 due to distribution without FDA premarket approval or clearance. The device was not cleared for sale in the U.S. The company classified the recall as active. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall guidance
100% of reported issues involve distribution without premarket approval. GET TESTED INTERNATIONAL AB’s HbA1c Diabetes Test was distributed nationwide in the United States without FDA clearance. Stop using the product immediately and follow the manufacturer’s recall instructions.
GET TESTED INTERNATIONAL AB recalled 1,557 Vitamin D-Tests on November 3, 2025, due to distribution without premarket approval. The recall affects devices distributed nationwide in the United States. Consumers should stop using the test immediately and follow manufacturer instructions.
GET TESTED INTERNATIONAL AB recalled the GI Microbiome Profile XL on November 3, 2025, due to distribution without premarket approval. Three units were distributed nationwide in the U.S. Patients and healthcare providers should stop using this device immediately.