www.fdanews.com/articles/145960-deteriorating-leads-spark-device-alert
Deteriorating Leads Spark Device Alert
April 27, 2012
Roche Diagnostics issued a device alert for its Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays. With certain types of plasma samples, doctors may receive a false result — up to 50 percent lower than the actual concentration of Troponin I. Incorrect results may cause have adverse health consequences, including death.