Randox Laboratories has recalled 666 units of its Cystatin C Calibrator (Series CVS 2699) used in medical laboratories. The product is exhibiting a 'negative bias,' meaning it may produce results that are lower than they should be when compared to other testing methods. This calibrator is used on automated analyzers to help measure Cystatin C levels, which are often used to check kidney function. These affected units were distributed in California and Indiana.
If the calibrator produces results that are too low, it could lead to the misinterpretation of a patient's kidney function. This may result in a healthcare provider making incorrect treatment decisions or failing to diagnose a medical condition based on inaccurate laboratory data.
Manufacturer Notification and Guidance
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.
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Sources: FDA iRES · Raw API Response
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