Randox Laboratories Ltd. has recalled 40 units of the Evidence MultiSTAT analyzer with software version 3.7. The device is used for the qualitative testing of drugs and their metabolites in human urine. A foam gasket on the chip heater assembly may fail to perform correctly, which can allow light to leak into the camera during the imaging process. This defect can interfere with the device's accuracy and cause delays in reporting critical test results. No specific injuries or incidents have been reported, but the mechanical failure directly impacts the reliability of the diagnostic data.
A faulty foam gasket allows light to leak into the internal camera (CCD) during the imaging phase of a test. This light interference can distort the results or prevent the device from successfully completing a test, leading to incorrect medical data or significant delays in patient diagnosis.
Maintenance/Repair of the chip heater assembly.
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Sources: FDA iRES · Raw API Response
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