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FDA Recalls Cardiac Diagnostic Tests

Nicholas Wills4 years ago

The FDA has recently issued a Class I recall affecting several lots and 98,000 kits from Alere Triage – a diagnostic test system – due to a potentially fatal sensitivity error that increases both false positive and false negative test results.

About the Cardiac Diagnostic Tests Recall

Alere Triage is made up of various test devices and a meter that are used to aid in the diagnosis of diseases and health conditions including heart failure and myocardial infarction (heart attack). The system is also used to assess patients for pulmonary embolism. There are reports of patients receiving inappropriate clinical management, which may have been due to the sensitivity error. In addition, the false results are unpredictable within lots and cannot be distinguished through quality control sampling. Alere Triage can potentially cause serious adverse health consequences, including death.


Customers are recommended to immediately discontinue all use and discard any remaining product and to use unaffected lots or alternative methods. There may not currently be a sufficient unaffected product to supply the demand for all laboratories. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA.

Description of Recalled Diagnostic Tests
  • These products were manufactured from 06/12/2011 to 04/08/2012. Distributed from 09/08/2011 to 06/05/2012, 98,100 test kits have the potential to be defective.
  • There have been two other times that Alere was required to recall its diagnostic tests. In the first, 803,000 tests were recalled. The second involved 605,000 recalls.
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