GET TESTED D-Dimer 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 D-Dimer Test products due to being distributed without premarket approval. This means the tests may not meet safety standards and could pose risks to users.

Why it’s dangerous

The tests were distributed without proper regulatory approval, which could mean they don't meet safety and quality standards. This might lead to inaccurate results or other health risks if used improperly.

Who’s affected

Anyone who purchased or uses the D-Dimer Test products. The risk is highest for individuals relying on these tests for medical purposes.

How to tell if you have this one

Check for the product name 'D-Dimer Test' with EAN 7340221700475 or SKU A-CDM. 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
Identify the product using the EAN 7340221700475 or SKU A-CDM.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The D-Dimer Test products were distributed without premarket approval, which may not meet safety and quality standards.

What should I do if I have this product?

The official recall notice does not specify a remedy or action for affected products.

Is there a risk of injury from this product?

The recall record does not describe specific injury risks, so the danger level is unknown.

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-0731-2026 — GET TESTED GET TESTED

Hello,

I own a GET TESTED that is covered by recall Z-0731-2026 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-0731-2026 (November 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0731-2026 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 D-Dimer Test

Recall notice