GET TESTED International AB recalls all H. pylori tests due to distribution without premarket approval. Consumers should check product details and contact the company for guidance.
Distribution without premarket approval/clearance.
GET TESTED International AB is recalling all H. pylori (peptic ulcer) tests because they were distributed without proper regulatory approval. This recall affects anyone who purchased these tests and may pose risks related to unapproved medical devices.
The tests were distributed without premarket approval or clearance from regulatory authorities. This means the product may not meet safety and efficacy standards, potentially leading to incorrect results or health risks if used improperly.
Anyone who purchased the H. pylori test kit from GET TESTED International AB. People with peptic ulcer concerns are most at risk due to potential unapproved medical device use.
Check for the EAN number 7340221700604 or SKU A-PYL on the product label. All lots of this test are affected by the recall.
Look for the EAN 7340221700604 or SKU A-PYL on the test kit label to confirm it is recalled.
The tests were distributed without premarket approval or clearance from regulatory authorities.
The recall does not specify a stop-use instruction; consumers should check product details and contact GET TESTED for guidance.
Check the EAN number 7340221700604 or SKU A-PYL on the product label. All lots of this test are affected.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0739-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0739-2026 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.
