The United States Food and Drug Administration (FDA) has issued a Class I recall concerning Triage CardioProfiler Panel (PN 97100CP), Triage Cardiac Panel (PN 97000HS), Triage Profiler SOB Panel (PN 97300), Triage BNP (PN 98000XR) and Triage D-dimer (PN 98100), manufactured by Alere San Diego, Inc..
Identified lots, manufactured from 06/12/2011 to 04/08/2012 and distributed from 09/08/2011 to 06/05/2012, may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. 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. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control 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.
For details, please refer to FDA website:
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm311387.htm and
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm311405.htm.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 12 July 2012