GET TESTED International AB recalls all Iron Deficiency Test products distributed without premarket approval. This recall addresses potential safety risks from unapproved distribution.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all Iron Deficiency Test products due to distribution without premarket approval. This means the products were not approved by the FDA before being sold, which could pose safety risks.
The test products were distributed without receiving premarket approval from the FDA. This means they were not tested for safety and effectiveness before being sold, which could lead to potential health risks.
Anyone who purchased or uses the Iron Deficiency Test product. People who rely on this test for medical purposes may be at risk.
The product is labeled as 'Iron Deficiency Test' with EAN 7340221700840 and SKU A-FER. All lots of this product are affected.
Look for the EAN 7340221700840 and SKU A-FER on the product label.
The product was distributed without premarket approval from the FDA, meaning it was not tested for safety and effectiveness before being sold.
The official recall notice does not specify a remedy or action for affected products.
The recall record does not describe any specific hazard that could cause injury.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0742-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0742-2026 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.
