Diagnostica Stago, Inc. is recalling approximately 34,000 STA Liatest D-Di kits because they may produce inaccurately high (positive bias) D-Dimer test results. These test kits are used by laboratory professionals to help rule out serious blood clotting conditions like pulmonary embolisms and deep vein thrombosis. The recall was initiated after customer complaints led to an investigation confirming that the measurement error exists across the entire testing range.
Inaccurate test results could lead to a false positive, potentially causing patients to undergo unnecessary medical procedures, imaging, or treatments for blood clots they do not have.
Full UDIs include manufacture and expiration dates: (1)(01)03607450005158(11)240630(17)250930(10)273015(241)00515 through (12)(01)03607450005158(11)251007(17)270131(10)274219.
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
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