Beckman Coulter has recalled approximately 13,565 units of its IGM reagent (REF: OSR61173) used in diagnostic laboratories. The recall was initiated because the settings used to check for lipemia (high fat content in the blood) are incorrect, which can interfere with accurate testing. This defect may cause patient samples to show falsely low results or cause a high result to appear within the normal range. Consumers and healthcare providers should contact the manufacturer to ensure their diagnostic equipment is updated with the correct settings.
The incorrect settings may fail to detect interference from fats in a patient's blood sample, leading to inaccurate medical test results. This could result in a physician missing a high immunoglobulin level or receiving a false low reading, potentially affecting patient diagnosis and treatment decisions.
Correct software/device settings
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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