GET TESTED International AB recalls pregnancy tests distributed without premarket approval. All lots are affected. Consumers should contact the company for details.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all pregnancy tests due to being distributed without proper regulatory approval. This means the tests may not be safe or effective for use.
The pregnancy tests were distributed without premarket approval, meaning they may not meet safety or effectiveness standards. This could lead to inaccurate results or potential health risks if used improperly.
Pregnancy test users who purchased the product from any retailer. Women who use these tests for pregnancy detection are at risk of using unapproved products.
The product is a pregnancy test with EAN: 7340221700697 and SKU: A-HCG. All lots are affected, so any pregnancy test from this manufacturer is included in the recall.
Reach out to GET TESTED International AB for specific instructions on how to handle the recalled product.
Yes, all lots of the pregnancy test with EAN 7340221700697 and SKU A-HCG are affected.
Contact GET TESTED International AB for specific instructions on handling the recalled product.
The recall states the tests were distributed without premarket approval, but no specific injury risks are mentioned.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0749-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0749-2026 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.