Beckman Coulter Inc. has recalled approximately 496 units of its Estrone RIA kits (REF: DSL8700) due to a manufacturing defect. A specific batch of bovine serum albumin used in the test tubes caused the kits to interact improperly with patient samples, leading to laboratory test results that are inaccurately high. These kits are diagnostic tools used for measuring estrone levels in human blood serum and plasma.
Falsely increased assay results can lead to incorrect medical diagnoses or inappropriate patient treatment decisions by healthcare providers.
Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
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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