Class IIOngoingZ-0814-2026
GET TESTED INTERNATIONAL AB recalls Pollen Allergy Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
System, Test, Radioallergosorbent (Rast) Immunological recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 14 recalls
Class IIOngoingZ-0813-2026
GET TESTED INTERNATIONAL AB recalls Pet Allergy Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0808-2026
GET TESTED INTERNATIONAL AB recalls Food Intolerance Test Small
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0807-2026
GET TESTED INTERNATIONAL AB recalls Food Intolerance Test Medium
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0806-2026
GET TESTED INTERNATIONAL AB recalls Food Intolerance Test Large
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0803-2026
GET TESTED INTERNATIONAL AB recalls Allergy test Small
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0769-2026
GET TESTED INTERNATIONAL AB recalls Allergy Test IgE
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0762-2026
GET TESTED INTERNATIONAL AB recalls Food Sensitivity Test Small
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0761-2026
GET TESTED INTERNATIONAL AB recalls Food Sensitivity Test Medium
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0760-2026
GET TESTED INTERNATIONAL AB recalls Food Sensitivity Test Large
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0759-2026
GET TESTED INTERNATIONAL AB recalls Food Allergy Panel Test (IgE)
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0493-2026
Siemens Healthcare Diagnostics, Inc. recalls Food Panel 3 Specific Allergen
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanne…
Siemens Healthcare Dia…MANov 19, 2025