Alere Triage Diagnostic Tests (Multiple Tests): Class I Recall - Potential for Significantly Decreased Precision

Including Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profiler SOB Panel, Triage BNP, and Triage D-dimer

[Posted 07/11/2012]

AUDIENCE: Laboratory, Cardiology, Pulmonology, Risk Manager

ISSUE: 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 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. See the Recall Notice for listings of identified Lot Numbers.

BACKGROUND: 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.

RECOMMENDATION: 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.

Healthcare professionals and patients are encouraged to 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:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[07/11/2012 - Recall Notice - FDA]