GET TESTED International AB recalls all 2-in-1 Trichomonas/Gard: Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
GET TESTED International AB is recalling all units of their 2-in-1 Trichomonas/Gardnerella test kits due to distribution without premarket approval. This means the product was not approved by health authorities before being sold, which could pose risks.
The product was distributed without premarket approval or clearance from health authorities. This means the tests may not meet safety or effectiveness standards, potentially leading to incorrect results or health risks if used improperly.
People who purchased or use the 2-in-1 Trichomonas/Gardnerella test kits from GET TESTED International AB. Those most at risk are individuals using the tests for medical purposes without proper regulatory approval.
Check for the product name '2 in 1 Trichomonas / Gardnerella Test' with EAN 7340221700925 or SKU B-TOG. All lots of this product are affected.
Identify the product using the EAN 7340221700925 or SKU B-TOG.
The recall record states the product was distributed without premarket approval, but does not specify if it is safe to use.
The recall record does not mention any remedy or replacement options.
The recall record does not specify actions for affected users beyond checking product details.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0816-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0816-2026 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.
