GET TESTED INTERNATIONAL AB recalls all Syphilis Tests due to distribution without premarket approval. This may pose risks to users. Contact for details.
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB is recalling all Syphilis Tests sold because they were distributed without proper regulatory approval. This could potentially lead to safety issues for users.
The tests were distributed without receiving necessary regulatory approval before being sold. This means they may not meet safety and quality standards, potentially causing inaccurate results or other health risks.
Anyone who purchased or uses the Syphilis Test. People who rely on these tests for medical screening may be at risk.
The Syphilis Test with EAN 7340221701656 and SKU A-ISY. All lots are affected.
Look for the EAN 7340221701656 and SKU A-ISY on the Syphilis Test packaging.
The Syphilis Tests were distributed without receiving necessary regulatory approval before being sold.
The official recall notice does not specify a remedy or action for affected products.
The recall indicates potential safety issues due to lack of regulatory approval, but specific risks are not detailed in the notice.
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-0751-2026 — GET TESTED INTERNATIONAL AB GET TESTED INTERNATIONAL AB Hello, I own a GET TESTED INTERNATIONAL AB that is covered by recall Z-0751-2026 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.
