GET TESTED International AB recalls iron deficiency ferritin tests due to distribution without premarket approval. All lots affected. No specific action steps provided in recall notice.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all iron deficiency ferritin tests because they were distributed without proper regulatory approval. This means the tests may not be safe or effective for use.
The tests were distributed without premarket approval, meaning they were not reviewed by regulatory authorities before being sold. This could lead to inaccurate test results, which might affect medical decisions.
Anyone who purchased or uses the iron deficiency ferritin test from GET TESTED International AB. People who rely on these tests for medical diagnosis are at risk of receiving inaccurate results.
The product is an iron deficiency ferritin test with EAN 616612785589 and SKU 1FE. All lots of this product are affected by the recall.
Look for the EAN 616612785589 and SKU 1FE on the test packaging.
The tests were distributed without premarket approval, meaning they were not reviewed by regulatory authorities before being sold.
The recall notice does not specify any action steps for affected products.
The recall is due to potential inaccurate results, not a physical hazard like injury or damage.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0811-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0811-2026 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.
