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Heart Test Recalled for Unpredictable False Results


Components of the Alere Triage test system, specifically, the Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profiler SOB Panel, Triage BNP, and Triage D-dimer, were voluntarily recalled on May 22, 2012.  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 and aid in assessing patients for pulmonary embolism. Customers were instructed to discontinue use of the affected product.

 

This product may cause serious adverse health consequences, including death. 98,100 test kits have the potential to be defective.

 

On June 11, 2012, the firm sent a second letter to customers with additional lots of Triage products to be recalled. A third letter dated June 12, 2012, included three more lots for the Triage Cardio Profiler Panel PN 97100CP and Alere Triage Profiler SOB Panel PN 97300. The letter informed the customers that the additional lots 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. 98,100 test kits have the potential to be defective.

 

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 the erroneous results.

 

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 is not known.

 

See the recall

 

 

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