Allergy & Food Intolerance Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
🔬
Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Ovulation Test (5 tests)
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Accriva Diagnostics
Class I - Dangerous
Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
Food Sensitivity Test Medium
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Men s Hormone Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
H pylori (Peptic ulcer) Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Patient Monitor MX550. Product Number: 866066.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Fecal Occult Blood Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Patient Monitor MX750. Product Number: 866471.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Women s Hormone Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Melatonin Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Patient Monitor MX450. Product Number: 866062.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
IBS Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Sorbitol Intolerance Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Environmental Pollutants Profile Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Vaginal PH Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Gut Microbiome Test Medium
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Estrogen & Progesterone Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Continuous Glucose Monitor (CGM)
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.