3 in 1 STI Test Recall: 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 units of their 3 in :1 STI Test product because it was distributed without proper premarket approval. This recall does not involve a safety hazard but addresses regulatory compliance issues.

Why it’s dangerous

The product was distributed without premarket approval or clearance from regulatory authorities. This means it may not meet safety standards, but the recall is for compliance reasons rather than an immediate safety hazard.

Who’s affected

Anyone who purchased the 3 in 1 STI Test product. The risk is low as the product itself is not hazardous but was distributed without regulatory approval.

How to tell if you have this one

Check for the product name '3 in 1 STI Test' with EAN 7340221704770 or SKU JD-3STI. 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

Contact Manufacturer
Reach out to GET TESTED INTERNATIONAL AB for specific instructions on what to do with the product.

✎ GovInfoNow

Questions people ask

Is this product dangerous?

No, the recall is for regulatory compliance, not a safety hazard.

How do I know if I have the recalled product?

Check for the product name '3 in 1 STI Test' with EAN 7340221704770 or SKU JD-3STI. All lots are affected.

What should I do with the product?

Contact GET TESTED INTERNATIONAL AB for specific instructions.

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-0817-2026 — GET TESTED GET TESTED

Hello,

I own a GET TESTED that is covered by recall Z-0817-2026 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-0817-2026 (November 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0817-2026 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 3 in 1 STI Test

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