BioCentury
ARTICLE | Company News

Alere sales and marketing update

July 16, 2012 7:00 AM UTC

Alere began recalling lots of Alere's Triage products following reports of decreased precision leading to false positive and false negative results. The recall includes Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profiler SOB Panel, Triage BNP and Triage D-dimer kits manufactured between June 12, 2011, and April 8, 2012. FDA said it received reports of patients receiving inappropriate clinical management possibly due to erroneous results. In March, FDA began an inspection of Alere's San Diego, Calif., facility related to Triage products. According to its latest 10Q, Alere said the agency "expressed concern about the alignment between certain aspects of our labeling for the Alere Triage products and the quality control release method that had been in effect prior to the inspection." ...