GET TESTED Candida Test: 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 Candida Test products due to being distributed without premarket approval. This means the product may not have been properly tested for safety before being sold.

Why it’s dangerous

The product was distributed without premarket approval, meaning it wasn't tested for safety before being sold. This could lead to potential health risks if the product is used without proper validation.

Who’s affected

Anyone who purchased the Candida Test product from any retailer. People using the product for medical testing are most at risk.

How to tell if you have this one

Check for the product name 'Candida Test' with EAN 7340221700888 or SKU B-CAN. 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 7340221700888 or SKU B-CAN on the product label.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall record states the product was distributed without premarket approval, but does not confirm if it is safe to use.

How do I know if I have the recalled product?

Check for the product name 'Candida Test' with EAN 7340221700888 or SKU B-CAN on the label.

What should I do if I have this product?

The recall record does not specify a remedy, so no action is required beyond checking if you have the product.

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-0729-2026 — GET TESTED GET TESTED

Hello,

I own a GET TESTED that is covered by recall Z-0729-2026 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-0729-2026 (November 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0729-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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 Candida Test

Recall notice