GET TESTED INTERNATIONAL AB recalls all HPV Antigen Tests due to distribution without premarket approval. This may pose regulatory risks but does not indicate immediate safety hazards.
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB is recalling all HPV Antigen Tests sold under the EAN 734:221708259. The recall is due to the product being distributed without proper regulatory approval, which could lead to compliance issues but does not indicate an immediate safety risk.
The product was distributed without receiving premarket approval or clearance from regulatory authorities. This means the test may not meet required safety and quality standards, potentially leading to regulatory non-compliance but not an immediate physical hazard.
Anyone who purchased or uses the HPV Antigen Test with the EAN 7340221708259. The recall applies to all units sold by the manufacturer.
Check for the EAN code 7340221708259 on the HPV Antigen Test packaging. All lots of this product are affected by the recall.
Identify the EAN code 7340221708259 on the HPV Antigen Test packaging to confirm if it is recalled.
The recall is due to distribution without premarket approval, not an immediate safety hazard. The product may not meet regulatory standards but does not pose a direct risk to users.
No immediate action is required as the recall does not indicate a safety risk. However, you should check the EAN code to confirm if it is affected.
The recall record does not mention a replacement option or remedy for affected products.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0741-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0741-2026 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.
