Iodine Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
All Recalls
95,064 total recalls in our database
MPOX Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
🏥 Medical Devices Class I - Dangerous
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
GI Microbiome Profile Small
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Parasite Test
GET TESTED INTERNATIONAL AB
🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Sperm Test
GET TESTED INTERNATIONAL AB
🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
DHEA Test
GET TESTED INTERNATIONAL AB
🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Serotonin Test
GET TESTED INTERNATIONAL AB
🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Female Fertility Test
GET TESTED INTERNATIONAL AB
🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Gut Microbiome Test Mega
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Multi Measurement Server X2. Product Number: M3002A.
Philips North America
🏥 Medical Devices Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Food Allergy Panel Test (IgE)
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Food Intolerance Test Large
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
NAD Profile Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Vitamin D2 and D3 Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
🏥 Medical Devices Class I - Dangerous
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Leaky Gut Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Kidney Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
2 in 1 Trichomonas / Gardnerella Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Menopause (FSH) 2 Tests
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.