GET TESTED INTERNATIONAL AB recalls all MPOX Test products 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 MPO: Test products because they were distributed without proper regulatory approval. This recall does not indicate an immediate safety risk to users.
The product was distributed without premarket approval, meaning it may not meet regulatory standards. However, the recall does not specify any immediate safety hazards or risks to users.
Anyone who purchased or uses the MPOX Test product. The recall applies to all units sold.
Check for the product name 'MPOX Test' with EAN 7340221708976 or SKU A-MPVAR. All lots are affected.
Identify the product using the EAN 7340221708976 or SKU A-MPVAR.
The recall states distribution without premarket approval but does not indicate immediate safety hazards.
Check for the product name 'MPOX Test' with EAN 7340221708976 or SKU A-MPVAR; all lots are affected.
The recall does not specify a remedy, so no action is required beyond checking product details.
We’ve drafted a message you can send GET TESTED INTERNATIONAL to request your refund or repair — edit it as you like.
Subject: Recall Z-0745-2026 — GET TESTED INTERNATIONAL GET TESTED INTERNATIONAL Hello, I own a GET TESTED INTERNATIONAL that is covered by recall Z-0745-2026 from GET TESTED INTERNATIONAL. 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.
