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FDA recalled rapid cardiac diagnostic tests
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The FDA has issued a Class I recall of Alere Triage products due to their potential to increase the frequency of false positive or false negative test results, according to a press release.
The agency reported that the affected products, including Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profile SOB Panel, Triage BNP and Triage D-dimer, may have significantly decreased precision relative to the package insert. The false positive and false negative results are unpredictable within the recalled lots and may not be detected by quality control testing.
Further, certain lots have a higher frequency of troponin I results greater than 0.05 ng/mL for samples that are found to be below 0.05 ng/mL upon additional testing.
The release stated that there have been reports of patients receiving inappropriate clinical management that may be related to erroneous results.
The affected products were manufactured from June 12, 2011 to April 8, 2012 and distributed from September 8, 2011 to June 5, 2012. A total of 98,100 kits may be defective.
This current Class I recall follows an urgent recall issued by Alere on May 22.
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 HF, MI and pulmonary embolism.
The FDA recommends that customers immediately discontinue all use and discard any remaining product and use unaffected lots or alternative methods for measuring these analytes.