BioReference Health, LLC is recalling The 4Kscore Test system, which includes 3,196 individual tests. This medical test is used to predict prostate cancer risk by combining several blood markers with patient information like age and biopsy history. The recall was initiated because recent mathematical modeling showed that the Digital Rectal Exam (DRE) information, which is a required component of the test's scoring algorithm, was not properly incorporated into the results. Consumers who have had this test should consult their healthcare provider to discuss how this modeling issue may have impacted their specific results.
The 4Kscore results may be inaccurate if the required Digital Rectal Exam (DRE) data is not properly modeled within the final score calculation. This could lead to an incorrect assessment of a patient's risk for aggressive prostate cancer, potentially affecting subsequent treatment or biopsy decisions.
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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
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