FDA Class I Recall Made for Alere Triage Troponin Tests
July 16, 2012 — The U.S. Food and Drug Administration (FDA) 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 >0.05 ng/mL for samples that 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.
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.
These products were manufactured from June 12, 2011 to April 8, 2012. They were distributed from Sept. 8, 2011 to June 5, 2012. A total of 98,100 test kits have the potential to be defective. See the recall notice for listings of identified lot numbers.
The firm requests customers to immediately discontinue all use and discard any remaining product and to use unaffected lots or alternative methods for measuring these analytes. There may not currently be sufficient unaffected product to supply the product demand for all laboratories. The duration of supply disruptions are not known.
For more information: www.fda.gov/MedWatch/report.htm