GET TESTED INTERNATIONAL AB: Epstein-Barr Virus Test Recalled Due to Unapproved Distribution

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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 has recalled all Epstein-Barr Virus (EBV VCA & EBNA IgG) tests because they were distributed without proper regulatory approval. This means the tests may not be safe or effective for use.

Why it’s dangerous

The tests were distributed without premarket approval, meaning they haven't been reviewed by regulatory authorities for safety and effectiveness. This could lead to inaccurate results or health risks if used improperly.

Who’s affected

Anyone who purchased or uses the Epstein-Barr Virus test kits from GET TESTED INTERNATIONAL AB. People who rely on these tests for medical diagnosis are most at risk.

How to tell if you have this one

The test kits have the EAN number 7340221708211 and SKU A-EBV. All lots of these tests are affected, so check any packaging for these identifiers.

Brand
GET TESTED INTERNATIONAL
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the EAN number 7340221708211 or SKU A-EBV on the test kit packaging to confirm if it's affected.

✎ GovInfoNow

Questions people ask

Why is this test being recalled?

The tests were distributed without premarket approval, meaning they haven't been reviewed by regulatory authorities for safety and effectiveness.

What should I do if I have this test?

The recall notice does not specify any action steps for affected products.

Are all versions of this test affected?

Yes, all lots of the Epstein-Barr Virus (EBV VCA & EBNA IgG) tests with EAN 7340221708211 and SKU A-EBV are affected.

Take action

Contact GET TESTED INTERNATIONAL

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

✉️ Open in email

Subject: Recall Z-0735-2026 — GET TESTED INTERNATIONAL GET TESTED INTERNATIONAL

Hello,

I own a GET TESTED INTERNATIONAL that is covered by recall Z-0735-2026 from GET TESTED INTERNATIONAL.

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-0735-2026 (November 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0735-2026 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 Epstein-Barr Virus (EBV VCA & EBNA IgG) Test

Recall notice