Updated: FDA Warns Abaxis Over Adulterated, Misbranded Assay
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 12 April to Union City, CA-based Abaxis after it found that an assay the firm sells is a Class III device and has not been approved as such.FDA found the company’s Piccolo Potassium assay, used with the Piccolo Xpress chemistry analyzer, is a Class III device and therefore both adulterated and misbranded.
“Specifically, your firm made changes that affected the potassium assay calibration specifications and ultimately changed the performance of the device, as demonstrated by customer complaints,” the warning letter says.
“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; thus, this change requires a new premarket notification (510(k)).”
Abaxis, which responded to FDA five times in 2018, did not alter the agency’s conclusions that a new 510(k) is required for the device modifications.
FDA also took issue with the firm’s failure to establish design change procedures, such as when it “made a change to the potassium assay calibration in October 2013 without establishing pre-approved acceptance criteria or evidence of performance of risk evaluation.”
The warning letter comes as animal health company Zoetis acquired Abaxis last year for $2 billion.
Zoetis told Focus in a statement: "The letter cites calibration changes in the potassium assay made to the Piccolo Xpress product that predated Zoetis’s acquisition of Abaxis in July 2018. FDA asserts that Abaxis should have submitted a new premarket notification (510(k)) to cover those changes. Zoetis takes this Warning Letter seriously. We have reached out to FDA and are working diligently with the FDA to resolve this matter."
Warning Letter
Article updated on 4/24/19 with comment from Zoetis.