Randox Laboratories Ltd. has recalled 269 kits of Calibration Serum Level 3 (product code CAL2351) used for medical testing. The recall was initiated because the product is running with a positive bias of up to 13% on RX Series instruments, which can lead to shifts in Quality Control and inaccurate patient sample results. This defect was identified during internal monitoring and affects specific lots distributed across the United States and Puerto Rico.
A positive bias of up to 13% in calibration can cause medical instruments to report incorrectly high patient results for 'CK Total' tests. Inaccurate lab results could lead to incorrect medical diagnoses or inappropriate treatment decisions by healthcare providers.
Manufacturer Notification and Medical 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.
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Sources: FDA iRES · Raw API Response
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