Abaxis Warned on Piccolo Xpress Issues

A 4/9-4/25/18 FDA inspection of Abaxis, Inc., Union City, CA, found violations in the firm’s manufacturing and distribution of Class 1 and Class 2 in-vitro diagnostic reagents including the Piccolo Xpress chemistry analyzer and associated rotor panels/assays. A 4/12 Warning Letter says the Piccolo potassium assay is a Class 3 device that does not have an approved application for premarket approval in effect and is misbranded because the firm made changes that affected the assay calibration specifications and ultimately changed the device performance as demonstrated by customer complaints.

The letter also identifies specific deficiencies in the firm’s quality system in that it failed to establish design change procedures.

Abaxis’ responses to the inspection observations were not adequate, the letter says. The company was told to investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the products into compliance.