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 its Sorbitol Intolerance Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 6 units of its Food Intolerance Test Large because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 10 units of its Vitamin D2 and D3 Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 18 units of its Neurotransmitters Plus because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 50 units of its Heavy Metals Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 4 units of its Continuous Glucose Monitor (CGM) because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 5 units of its Food Intolerance Test Small because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 109 units of its Candida Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 71 units of its Allergy Test IgE because the product was distributed without premarket approval or clearance.
American Nuts is recalling 2,700 units of Dry Roasted Baking Macadamia Nuts over potential Salmonella contamination. The FDA has classified the action as Class I.
Get Tested International AB is recalling 18 units of its Neurotransmitters Basic because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 1 unit of its Alcohol (ALC) Test Saliva because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 27 units of its PSA Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 6 units of its Gut Microbiome Test Small because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 2043 units of its 8 in 1 STI Test Kit because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 24 units of its Akkermansia Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 16 units of its Food Intolerance Test Medium because the product was distributed without premarket approval or clearance.