DHEA Test
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
🏥 Medical Devices • 6,627 recalls
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
Philips North America
Potential issue where the IntelliVue monitors did not alarm.