GET TESTED INTERNATIONAL recalls all herpes (HSV-1 & HSV-2) tests due to distribution without premarket approval. This may pose regulatory risks but does not indicate a safety hazard for users.
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL is recalling all herpes (HSV-1 and HSV-2) tests because they were distributed without proper regulatory approval. This recall does not involve a safety risk to users but is a regulatory action.
The tests were distributed without premarket approval, meaning they were not reviewed by regulatory authorities before being sold. This is a regulatory issue, not a safety hazard for users.
Anyone who purchased or uses the herpes tests from GET TESTED INTERNATIONAL. The recall applies to all units sold.
The herpes tests with EAN 7340221710047 and SKU A-HSV. All lots are affected, so every unit is included in this recall.
Identify the EAN 7340221710047 and SKU A-HSV on the test packaging.
No, this recall is a regulatory action due to distribution without premarket approval. It does not pose a safety risk to users.
No, the recall does not require stopping use. This is a regulatory action, not a safety hazard.
The official notice does not specify a remedy, so no action is required beyond checking the 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-0740-2026 — GET TESTED INTERNATIONAL GET TESTED INTERNATIONAL Hello, I own a GET TESTED INTERNATIONAL that is covered by recall Z-0740-2026 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.
