The FDA issued a Class 1 recall of Alere Triage cardiac diagnostic products because the rapid test system has the potential to be defective.
According to the FDA notification, 98,100 test kits that were distributed between Sept. 8, 2011, and June 5, 2012 are prone to errors that could result in an increased frequency of false positive or false negative results. The agency warned that these false positive and negative results may not be detected in quality control testing.
“There have been reports of patients receiving inappropriate clinical management which may have been due to such erroneous results,” the FDA wrote in a recall notice that was released July 11. “This product may cause serious adverse health consequences, including death.”
The recall affects the Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profiler SOB Panel, Triage BNP and Triage D-dimer products manufactured between June 12, 2011, and April 8, 2012. The test devices are used to help diagnose cardiac diseases and conditions, including heart failure and myocardial infarction as well as aid in assessing patients for pulmonary embolism.
The Class 1 notification follows a letter issued May 22 by Alere informing clients that it had initiated a voluntary recall. Waltham, Mass.-based Alere is asking customers to immediately discontinue all use and discard any remaining product and to use unaffected lots or alternative measurement methods.
The FDA also recommends that healthcare professionals and patients report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.