Changchun Wancheng Bio-Electron Co., Ltd. is recalling approximately 139,966 units of various diagnostic test strips, including UTI, ketone, ovulation, and fertility tests, because they were distributed in the U.S. without the required legal marketing clearance (510(k)). These devices were sold under multiple brand names including LotFancy, Vivoo, JNW Direct, and Urinify. Using these unvetted tests may result in false or inaccurate diagnostic results, which could lead to inappropriate medical treatments or delayed care for serious conditions.
Inaccurate results from these unapproved tests could cause a person to believe they have a medical condition they do not, or miss a condition they do have, leading to improper medical intervention or a failure to seek necessary treatment. No specific injuries have been reported to date, but the lack of FDA review means the performance and safety of these tests have not been verified.
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Quantity: 91,366 units
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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.