GI Microbiome Profile Small
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Parasite Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Sperm Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
DHEA Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Serotonin Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Female Fertility Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Gut Microbiome Test Mega
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Multi Measurement Server X2. Product Number: M3002A.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Food Allergy Panel Test (IgE)
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Food Intolerance Test Large
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
NAD Profile Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Vitamin D2 and D3 Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Leaky Gut Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Kidney Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
2 in 1 Trichomonas / Gardnerella Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Menopause (FSH) 2 Tests
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Blood Type Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
3 in 1 STI Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue MP60. Product Number: M8005A.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.