Alere's Triage tests facing potential recall after FDA warning
This article was originally published in Clinica
Executive Summary
Alere's Triage cardiology and toxicology tests could be recalled, after the US FDA sent the company a subpoena relating to quality control testing and performance of the diagnostics. Although the company did not put a figure on the financial impact of a potential recall, Canaccord Genuity analyst Jeffrey Frelick noted that the FDA appears to be focused on the firm's Triage multi-marker cardiology tests, which contribute around $20m of revenues per quarter.