Alere Triage Diagnostic Tests (Multiple Tests): Class I Recall - Potential for Significantly Decreased Precision
MedSun: Newsletter #75, August 2012

FDA MedWatch Safety Alert

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. There have been reports of patients receiving inappropriate clinical management which may have been due to such erroneous results.

Additional Information:

FDA MedWatch Safety Alert. Alere Triage Diagnostic Tests (Multiple Tests): Class I Recall - Potential for Significantly Decreased Precision. July 11, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm311405.htm