Alere Triage Diagnostic Test Recall Due to Potentially Bad Results

Federal health regulators warn that a product used to diagnose heart failure and heart disease may produce bad test results, possibly leading to injury and death for patients. 

The FDA notified healthcare professionals this week that an Alere Triage recall should be considered a Class I recall, suggesting that continued use of the diagnostic test poses a reasonable probability of serious health consequences.

According to the Alere Triage recall notice, originally issued in May, the tests 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 recalled lots have increased frequency of false positive Troponin I results, the report indicates. These false positive and false negative results are unpredictable within lots and may not be detected by quality control testing.

The devices affected are Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profiler SOB Panel, Triage BNP, and Triage D-dimer. The recall affects 49 lots of the test kits manufactured between June 12, 2011 and April 8, 2012.

According to Alere, about 70 percent of U.S. hospitals use the diagnostic tests. They are also available in more than 50 international markets. A statement from Alere indicates the duration of supply disruptions are not known.

The FDA encourages healthcare professionals to immediately discontinue all use of the recalled products and lots and switch to an alternative method for measuring these analytes if no unaffected lots are available. However, if there are no alternate method, Alere recommends performing a validation of the affected lot(s) until an alternative method is found. The company also recommends testing samples in duplicate.

The FDA recommends that healthcare professionals and patients report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Last month, Alere recalled 897,000 tests used to detect heart attacks and drug use because of quality control flaws. According to reports, the 650,000 cardiology tests were used to diagnose heart attacks and manage heart failure, while 247,000 Triage Tox tests were used by hospitals to identify 11 different substances including acetaminophen, cocaine, and marijuana. Most of the products were manufactured last year, the company said in a regulatory filing in June.