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 10 units of its Pollen Allergy Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 19 units of its Allergy test Small because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 4 units of its Gut Microbiome Test XL because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 463 units of its Gonorrhea test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 29 units of its Pet Allergy Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 2 units of its Mycotoxin Panel Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 9 units of its Estrogen & Progesterone Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 1 unit of its Sperm Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 45 units of its Intestinal Worms Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 1 unit of its Drug Test Small (4 substances) because the product was distributed without premarket approval or clearance.
Hale inc is recalling 54 bottles of Lotsa Pasta Roasted Garlic Infused Olive Oil over the potential for Clostridium botulinum contamination.
Get Tested International AB is recalling 8 units of its Fructose Intolerance Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 5187 units of its Iron Deficiency Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 1557 units of its Vitamin D-Test because the product was distributed without premarket approval or clearance.
Philips North America is recalling the IntelliVue Patient Monitor MX450 over a potential issue where the monitors did not alarm.
Get Tested International AB is recalling 35 units of its Fecal Occult Blood Test because the product was distributed without premarket approval or clearance.
Blossom Pharmaceuticals is recalling 2400 containers of Wecare Calasoothe over current good manufacturing practice deviations.
Get Tested International AB is recalling 14 units of its Neurotransmitters XL because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 1210 units of its 3 in 1 STI Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 15 units of its Lactose Intolerance Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 4081 units of its Epstein-Barr Virus (EBV VCA & EBNA IgG) Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 754 units of its 2 in 1 Trichomonas / Gardnerella Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 31 units of its Vaginal PH Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 37 units of its Women's Hormone Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 239 units of its H pylori (Peptic ulcer) Test because the product was distributed without premarket approval or clearance.