FDA (Devices) recall action 97896
The FDA (Devices) publishes a recall like this one as 92 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 92 pages.
Distribution without premarket approval/clearance.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Get Tested International AB is recalling 55 units of its SIBO Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 3 units of its Gut Microbiome Test Large because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 1916 units of its Thyroid TSH Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 128 units of its Ovulation Test (5 tests) because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 12 units of its Serotonin Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 5 units of its Chlamydia Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling its Liver Test because the product was distributed without premarket approval or clearance.
Philips North America is recalling the IntelliVue MP2 over a potential issue where the monitors did not alarm.
Get Tested International AB is recalling 3 units of its Gut Microbiome Test Medium because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 1361 units of its Herpes (HSV-1 & HSV-2) Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 48 units of its Diabetes Test (ketones & glucose) because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 16 units of its Allergy & Food Intolerance Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 1 unit of its Organic Acids Profile Test Large because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 3 units of its GI Microbiome Profile XL because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 1 unit of its Food Sensitivity Test Medium because the product was distributed without premarket approval or clearance.
Philips North America is recalling the IntelliVue Multi-Measurement Module X3 over a potential issue where the monitors did not alarm.
Get Tested International AB is recalling 60 units of its Trichomonas Vaginalis test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 528 units of its Syphilis Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 76 units of its Allergy test Small because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 1218 units of its D-Dimer Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 3 units of its Biological Age & Longevity Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 12 units of its Melatonin Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 33 units of its Sperm Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 4 units of its Organic acids Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 115 units of its Iron Deficiency Test (ferritin) because the product was distributed without premarket approval or clearance.