GET TESTED INTERNATIONAL AB recalled 5 units of its Food Intolerance Test Small on November 3, 2025. The recall follows the distribution of the device without necessary premarket approval. Healthcare providers and patients must cease use immediately and follow the manufacturer's instructions.
Distribution without premarket approval/clearance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The Food Intolerance Test Small is designed to help individuals identify food intolerances. Consumers typically purchase such tests to manage dietary sensitivities and improve their overall health.
The lack of premarket approval means the device has not undergone the necessary evaluations to ensure its safety and efficacy for consumers. This could lead to inaccurate results and health risks.
This recall is not part of a broader industry pattern.
Consumers who possess this device are urged to stop using it immediately, which may cause inconvenience for those relying on it for dietary management.
Model numbers and lot numbers can typically be found on the product packaging or the device itself.
Expect 4-6 weeks for refund or replacement processing from the manufacturer.
Keep a copy of the recall notification, any correspondence with the manufacturer, and receipts as proof of purchase.
The Food Intolerance Test Small is classified as a Class II medical device. It was distributed nationwide in the US. The model numbers affected include EAN: 616612785626, SKU: 1G1, and all lots.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
GET TESTED INTERNATIONAL AB recalled 528 syphilis tests distributed nationwide in the United States. The tests were distributed without premarket approval or clearance. Patients and healthcare providers should stop using them immediately and follow the manufacturer's recall instructions.
GET TESTED INTERNATIONAL AB recalled 19 Hair Mineral Analysis devices distributed nationwide in the United States. The recall cites distribution without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and contact GET TESTED INTERNATIONAL AB or their healthcare provider for instructions.
GET TESTED INTERNATIONAL AB recalled 33 units of its sperm test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled 109 units of its Candida Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers should stop using this device immediately.
GET TESTED INTERNATIONAL AB recalled 76 units of its Allergy Test on November 3, 2025. The recall occurred due to distribution without premarket approval. Patients and healthcare providers should stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled 94 units of its Parasite Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients should stop using the device immediately and follow provided instructions.
GET TESTED INTERNATIONAL AB recalled 2,043 units of an 8 in 1 STI Test Kit sold nationwide in the United States. The recall is for distribution without premarket FDA approval or clearance. Consumers should stop using the device and follow the manufacturer’s recall instructions or contact the company for guidance.
GET TESTED INTERNATIONAL AB distributed 1 unit nationwide in the United States. The device lacked premarket approval or clearance. Stop using the product immediately and contact GET TESTED INTERNATIONAL AB for instructions.