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Medical Devices / Regulatory Affairs

Abaxis Gets Warning Letter for Adulterated Potassium Diagnostic

April 25, 2019
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Abaxis was hit with an FDA warning letter over changes it made to a potassium assay used with its chemistry analyzer device that caused the product to be adulterated and misbranded.

The agency said that the Union City, California devicemaker made modifications that altered the potassium diagnostic’s calibration specifications and changed the performance of the device, for which the company received customer complaints.

The device requires a new 510(k) clearance, the FDA said, because the altered calibration raises “new issues of safety and effectiveness since a falsely low potassium result could lead to serious adverse consequences such as delay in treatment or no treatment” for high potassium in the blood.

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