federal law violation Recalls

GET TESTED INTERNATIONAL AB Vitamin D2 and D3 Test Recall 10 Units Sold Nationwide (2025)

Distribution without premarket approval/clearance.

Get Tested International AB Leaky Gut Test Recalled for Lack of FDA Approval (31 Units)

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Recalled 754 Units of 2 in 1 Trichomonas / Gardnerella Test (2025)

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Syphilis Test Recalled in 2025 for PMA Lapse Nationwide

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Issues Recall of Alcohol Test Kit

Distribution without premarket approval/clearance.

Nissan Recalls 2025 Sentra for Driver Seat Frame Security Issue

GET TESTED INTERNATIONAL AB Ferritin Iron Deficiency Test Recalled for Premarket Approval Issue (202

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Candida Test Recalled for 166 Units in 2025

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Thyroid TSH Test Recalled Over PMA Issue (1,916 Units)

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB DHEA Test Recalled for Premarket-Approval Lapse, 17 Units (2025)

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Recalls Parasite Test Over Approval Issues

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 Drug Test Small (4 Substances) Recall 2025

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.

GET TESTED INTERNATIONAL Gut Microbiome Test Large Recalled for Premarket-Approval Violation (2025)

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Allergy Test Small Recalled for Lack of Premarket Approval (2025)

Distribution without premarket approval/clearance.

Get Tested International AB 3 in 1 STI Test Recalled for Premarket Approval Issue (2025)

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB IgE Food Allergy Panel Test Recalled in 2025

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Female Fertility Test Recalled for Premarket Approval Violation (31Units

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Intestinal Worms Test Recalled for 45 Units Nationwide in 2025

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Recalls Mycoplasma Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 23 units of its Mycoplasma test on November 3, 2025. The recall occurred due to distribution without premarket approval, classified as Class II. Patients and healthcare providers must stop using the device immediately.

GET TESTED INTERNATIONAL AB Fructose Intolerance Test Recalled for 8 Units (2025)

Distribution without premarket approval/clearance.