GET TESTED Food Intolerance Test Medium: Distribution Without Premarket Approval

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Recalling firmGET TESTED INTERNATIONAL AB59334 Vastervik, Lysingsvagen 18 · Vastervik, N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

GET TESTED International AB is recalling all Food Intolerance Test Medium products because they were distributed without proper regulatory approval. This means the product may not be safe for use as intended.

Why it’s dangerous

The product was distributed without premarket approval, meaning it may not have been tested for safety or effectiveness before being sold. This could lead to inaccurate results or health risks for users.

Who’s affected

Anyone who purchased the Food Intolerance Test Medium product. People with food allergies or sensitivities may be at higher risk if they use the test without proper approval.

How to tell if you have this one

Check for the product name 'Food Intolerance Test Medium' and the EAN code 616612785633. All lots of this product are affected.

Brand
GET TESTED
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the EAN code 616612785633 on the product label to confirm it's affected.

✎ GovInfoNow

Questions people ask

Is there a remedy for this recall?

The recall record states no remedy is provided.

How can I tell if I have the recalled product?

Check for the EAN code 616612785633 on the product label. All lots of this product are affected.

What is the risk of using this product?

The product was distributed without premarket approval, which may lead to inaccurate results or health risks.

Take action

Contact GET TESTED

We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0807-2026 — GET TESTED GET TESTED

Hello,

I own a GET TESTED that is covered by recall Z-0807-2026 from GET TESTED.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0807-2026 (November 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0807-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

GET TESTED INTERNATIONAL AB recalls Food Intolerance Test Medium

Recall notice