Men's Hormone Test Recalled: 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 has recalled all Men's Hormone Test products because they were distributed without proper medical approval. This product is not intended for medical use and no action is needed.

Why it’s dangerous

The product was distributed without medical approval, meaning it is not intended for use as a medical test. This could lead to incorrect results if used as a medical test, but the product is designed for non-medical purposes.

Who’s affected

Anyone who purchased the Men's Hormone Test product from any retailer. The product is not intended for medical use, so most people are not at risk.

How to tell if you have this one

Check for the product name 'Men's Hormone Test' with EAN 616612787002 or SKU O934. 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 product name 'Men's Hormone Test' with EAN 616612787002 or SKU O934.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

No, this product is not intended for medical use and should not be used as a medical test.

Do I need to do anything with this product?

No action is required as the product is not intended for medical use.

What is the recall number?

The recall number is not provided in the official notice.

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-0788-2026 — GET TESTED GET TESTED

Hello,

I own a GET TESTED that is covered by recall Z-0788-2026 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-0788-2026 (November 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0788-2026 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 Men s Hormone Test

Lower-risk recall