Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwedenLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Get Tested International with 92 device recalls. The most recent is a device recall dated Nov 3, 2025: Food Intolerance Test Small.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 3, 2025 | Food Intolerance Test SmallClass II · Distribution without premarket approval/clearance. | Device recalls |
| Nov 3, 2025 | Vitamin D-TestClass II · Distribution without premarket approval/clearance. | Device recalls |
| Nov 3, 2025 | Candida TestClass II · Distribution without premarket approval/clearance. | Device recalls |
| Nov 3, 2025 | Organic Acids Profile Test LargeClass II · Distribution without premarket approval/clearance. | Device recalls |
| Nov 3, 2025 | Allergy Test IgEClass II · Distribution without premarket approval/clearance. | Device recalls |
| Nov 3, 2025 | Allergy test SmallClass II · Distribution without premarket approval/clearance. | Device recalls |
| Nov 3, 2025 | GI Microbiome Profile XLClass II · Distribution without premarket approval/clearance. | Device recalls |
| Nov 3, 2025 | Illegally MarketedClass II · Distribution without premarket approval/clearance. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built