Latest FDA Warning Letter

FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below:

Abaxis, Union City, CA (4/12): FDA inspected the firm 4/9-25 and cited changes the company made to its Piccolo Xpress chemistry analyzer and associated rotor panels/assays. Specifically, the company made changes that affected the potassium assay calibration specifications and ultimately changed the performance of the device, as demonstrated by customer complaints. The letter said the changes to calibration set points raise 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 hyperkalemia. Additionally, the inspection cited deficiencies within Abaxis’ quality system pertaining to GMPs. For example, it failed to establish design change procedures.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm636172.htm