GET TESTED INTERNATIONAL AB recalls Allergy Test IgE products distributed without premarket approval. No specific action is required as the products are not approved for sale.
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB is recalling Allergy Test IgE products that were distributed without premarket approval. This recall does not require immediate action as the products are not approved for sale.
The products were distributed without premarket approval, meaning they were not reviewed by regulatory authorities before being sold. This could pose a risk if the products are used without proper safety testing.
Anyone who purchased the Allergy Test IgE products with the EAN 7340221707221 or SKU HT-IgE. The recall affects all lots of this product.
Check for the EAN number 7340221707221 or SKU HT-IgE on the product label. All lots of this product are affected by the recall.
Look for the EAN 7340221707221 or SKU HT-IgE on the product label to confirm if it is recalled.
No, the recall does not require stopping use as the products are not approved for sale.
The official notice does not specify any action required for these products.
The recall states the products were distributed without premarket approval, but no specific risks are mentioned.
We’ve drafted a message you can send GET TESTED INTERNATIONAL AB to request your refund or repair — edit it as you like.
Subject: Recall Z-0769-2026 — GET TESTED INTERNATIONAL AB GET TESTED INTERNATIONAL AB Hello, I own a GET TESTED INTERNATIONAL AB that is covered by recall Z-0769-2026 from GET TESTED INTERNATIONAL AB. 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.
