Princeton Biomeditech Corp is recalling the Osom Ultra hCG Combo Test (Model 1004) because it may provide false negative pregnancy test results. Approximately 1,860 kits, containing 50,220 individual test devices, are affected by this manufacturing issue. Two clinical false negative results were confirmed by ultrasound and lab tests, and six more tests failed during manufacturer investigation.
A false negative result means the test incorrectly indicates a person is not pregnant when they are. This can lead to delayed prenatal care or the unintentional use of medications and medical procedures that could harm a developing fetus.
Recall number Z-0259-2025; Each kit contains 50,220 individual test devices.
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.