GET TESTED International AB recalls Food Allergy Panel Test (IgE) due to distribution without premarket approval. All units are affected. No specific action is required per recall notice.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all Food Allergy Panel Test (Ig: IgE) products because they were distributed without proper regulatory approval. This recall does not require immediate action from consumers.
The test was distributed without approval from regulatory authorities, which means it may not meet safety and quality standards. This could potentially lead to inaccurate results or health risks for users.
Anyone who purchased the Food Allergy Panel Test (IgE) from any source is affected. People with food allergies who use this test may be at risk due to the lack of premarket approval.
Check for the product name 'Food Allergy Panel Test (IgE)' on the label. The EAN number 7340221709157 and SKU U44 are also associated with this product.
Look for the EAN number 7340221709157 and SKU U44 on the label to confirm if the product is recalled.
The recall notice states the product was distributed without premarket approval, but does not specify any direct risk of injury or illness.
The recall does not require immediate action; consumers are not instructed to stop using the product.
Check the product label for the EAN number 7340221709157 and SKU U44 to confirm it is part of the recall.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0759-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0759-2026 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.
