GET TESTED International AB recalls all Peptic Ulcer Test (H. pylori) products distributed without premarket approval. No immediate action needed as the test is not harmful but must be used with caution.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all Peptic Ulcer Test (H. pyl: pylori) products due to being distributed without premarket approval. This means the test may not meet safety standards, but it does not pose an immediate health risk.
The test was distributed without proper premarket approval, meaning it may not meet safety standards. However, the test itself does not cause harm and is not a health risk when used correctly.
Anyone who purchased the Peptic Ulcer Test (H. pylori) from GET TESTED International AB. People with peptic ulcers or those needing H. pylori testing are most at risk.
Check for the product name 'Peptic Ulcer Test (H. pylori)' and the EAN number 616612787309 or SKU 2-B220. All lots of this product are affected.
Verify the product name and EAN number 616612787309 or SKU 2-B220 to confirm if it's affected.
No, the test is not harmful but was distributed without premarket approval, so it may not meet safety standards.
No immediate action is needed as the test does not pose a health risk. However, you should check if it's affected by the recall.
Check for the product name 'Peptic Ulcer Test (H. pylori)' and the EAN number 616612787309 or SKU 2-B220.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0794-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0794-2026 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.
