GET TESTED International AB recalls Mycoplasma IgG/IgM tests due to distribution without premarket approval. All lots are affected. No remedy provided in official notice.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all Mycoplasma IgG and IgM tests because they were distributed without proper regulatory approval. This means the tests may not be safe or effective for use.
The tests were distributed without approval from health authorities, which could mean they don't meet safety or effectiveness standards. This might lead to incorrect health results or harm if used improperly.
Anyone who purchased or uses these Mycoplasma tests. People who rely on these tests for medical diagnosis are most at risk.
Check for the EAN number 7340221710030 or SKU A-MYC on the test packaging. All lots of this product are affected.
Look for the EAN 7340221710030 or SKU A-MYC on the test packaging to confirm if it's recalled.
The official recall notice states the tests were distributed without premarket approval, so safety is not guaranteed. No remedy is provided.
The official notice does not mention any remedy or replacement options.
The recall notice does not specify a deadline for action.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0746-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0746-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
