GET TESTED International AB recalls all Candida Test products due to distribution without premarket approval. Consumers should contact the company for details.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all Candida Test products because they were distributed without proper regulatory approval. This recall is due to the product not having been cleared by the appropriate authorities before being sold.
The product was distributed without premarket approval, meaning it did not undergo the required regulatory review before being sold. This could lead to potential safety issues if the product is used without proper oversight.
Anyone who purchased the Candida Test product from any retailer. People using the test for medical purposes may be at risk if the product was not properly approved.
The Candida Test product with EAN 616612785916 and SKU 2A120. All lots of this product are affected.
Reach out to GET TESTED International AB for specific instructions on how to handle the recalled product.
The recall record states the product was distributed without premarket approval, but does not specify if it is safe to use.
Look for the EAN 616612785916 and SKU 2A120 on the product label. All lots are affected.
The recall record does not specify a remedy, so contact GET TESTED International AB for instructions.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0775-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0775-2026 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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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.
