GET TESTED INTERNATIONAL AB is recalling approximately 25,201 units of various diagnostic test kits because they were distributed in the United States without required premarket approval or clearance from the FDA. These kits, which test for conditions ranging from STIs and hormones to food sensitivities and chronic diseases, have not been reviewed by the agency for safety or accuracy. Using unapproved tests can lead to misleading results, which may cause individuals to seek unnecessary medical treatment or fail to seek care for a serious health condition.
The lack of FDA review means these tests may provide false positive or false negative results, posing a risk that medical decisions will be based on inaccurate data. There are no reported injuries or incidents specifically mentioned in this recall, but the potential for improper disease management is high.
Recall #: Z-0727-2026
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If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.