FDA Class I Recall of Alere Triage Products

Washington, DC: The Food and Drug Administration (FDA) has notified healthcare professionals of a Class I Recall of Alere Triage products. Identified lots may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing. Certain lots affected have an increased frequency of Troponin I results greater than 0.05 ng/mL for samples which are found to be below 0.05 ng/mL upon additional testing.

There have been reports of patients receiving inappropriate clinical management which may have been due to such erroneous results. This product may cause serious adverse health consequences, including death.

These products were manufactured from 06/12/2011 to 04/08/2012. Distributed from 09/08/2011 to 06/05/2012: 98,100 test kits have the potential to be defective.

Alere Triage is a rapid diagnostic test system comprised of a meter and various test devices that aid in the diagnosis of diseases and health conditions including heart failure and myocardial infarction as well as aid in assessing patients for pulmonary embolism.
 

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Last updated on Sep-22-16