Randox Laboratories Ltd. has recalled 1,764 units of its Liquid Protein Calibrators used for medical testing. These calibrators, specifically the C3 and Haptoglobin components, were realigned to a different reference material (ERM-DA470k/IFCC), which may affect the accuracy of laboratory assay results. These products are used with Randox IgA, IgG, and IgM assays that require samples to be diluted before testing. Consumers should contact their healthcare provider or the manufacturer regarding these affected units sold in several U.S. states.
The realignment of the C3 and Haptoglobin calibrator materials may lead to inconsistent or inaccurate measurement results during diagnostic testing. Incorrect calibrator values can result in misleading patient test data, potentially affecting medical diagnoses or treatment decisions.
Product realignment and notification
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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