Allergy test small devices distributed without premarket approval. Recalled due to unapproved distribution.
Distribution without premarket approval/clearance.
Allergy test small devices are being recalled because they were distributed without proper premarket approval. This means the products were not tested or approved by the FDA before being sold.
The devices were distributed without premarket approval, meaning they were not tested or approved by the FDA before being sold. This could lead to inaccurate results or health risks if used improperly.
Anyone who purchased the allergy test small devices. People using these tests for medical purposes are most at risk.
Look for the product name 'Allergy test Small' with EAN 616612785503 or SKU 1000. All lots of this product are affected.
Identify the product by its EAN number 616612785503 or SKU 1000.
The devices were distributed without premarket approval, meaning they were not tested or approved by the FDA before being sold.
Look for the product name 'Allergy test Small' with EAN 616612785503 or SKU 1000. All lots of this product are affected.
The recall record does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0803-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0803-2026 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.
