A testing system commonly used to diagnose heart problems and other medical conditions has been recalled by the U.S. Food and Drug Administration.
In the recall notice FDA officials noted that identified lots of the Alere Triage test kits could have significantly decreased precision and may result in false positive or false negative results.
Quality control testing may not accurately determine which test kits have decreased precision since the reliability of test kits within the recalled lots are unpredictable.
The Alere Triage System features a meter and various test devices to help diagnose health conditions including heart attack, heart failure and pulmonary embolism.
According to Alere, about 70 percent of U.S. hospitals use the diagnostic tests. They also are available in more than 50 international markets.
The issued Class I recall is the most serious that the FDA issues, and suggests the product could result in serious adverse injury or death.
Affected in the recall are 49 lots of the test kits manufactured between June 12, 2011 and April 8, 2012. Certain recalled lots have increased frequency of false positive Troponin I results.
The FDA has received reports that some patients have received inappropriate clinical treatment, which may have resulted from inaccurate testing results.
Hospitals that use the tests have been asked to discontinue use of the test kits and discard remaining products. The recall could result in a supply shortage among medical centers and laboratories. It is not known how long supply may be disrupted.
Coronary artery disease is the leading cause of death in the United States and in the rest of the world. Estimates point to almost one half of all middle aged men and one third of all middle aged women in the United States developing some form of CAD. The primary symptom of angina, commonly known as chest pain, occurs when the artery is almost completely blocked.
Plaques made up of cholesterol and fibrous tissue lodge in the walls of the arteries that supply blood to the heart. Slow growth of the plaques can cause chest pain as they restrict blood flow to the heart muscle, and complete closure or rupture of the plaque can cause a myocardial infarction, commonly known as a heart attack, with resulting disability or death. CAD is primarily a disease of diet and habits, with the greatest risk factors coming from smoking, high blood pressure, high cholesterol, and diabetes.