Randox Laboratories has recalled two kits of its CRP Immunoturbidimetric reagent, which is a diagnostic tool used by healthcare providers to measure C-reactive protein levels in a patient's blood. The recall was initiated because the Antibody (R2 reagent) within these specific kits is showing a 'positive bias,' meaning it may provide higher-than-actual test results when testing patient samples. Because standard quality control tests do not show this same bias, a laboratory might not realize the test results are inaccurate, potentially leading to incorrect medical decisions.
The defect causes patient blood samples to show falsely elevated levels of C-reactive protein while quality control checks appear normal. This discrepancy could lead healthcare providers to misinterpret a patient's inflammatory status, potentially resulting in inappropriate clinical treatments or unnecessary further testing.
Manufacturer instructions for diagnostic device
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.
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Sources: FDA iRES · Raw API Response
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