Randox Laboratories has recalled 80,366 units of Clinical Chemistry Calibration Serum (Level 3) due to a defect where the inorganic phosphate component shows a negative bias on RX Series instruments. This means the serum, which is used to calibrate 38 common medical tests, provides inaccurate readings compared to standard methods. Affected units were distributed nationwide and include Catalog numbers CAL2351 and CAL10388. Consumers and healthcare providers should be aware that this defect can lead to incorrect diagnostic readings for patients.
The calibration serum provides a 'negative bias' for inorganic phosphate, which can cause laboratory instruments to report lower-than-actual phosphate levels in patient samples. This inaccuracy could lead to clinical misinterpretation or incorrect treatment decisions by healthcare providers.
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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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