(RxWiki News) 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.
"Patients are encouraged to report adverse impacts associated with the test kits."
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.