FDA Issues Class I Recall of Cardiovascular Diagnostic Tests

July 12th, 2012

FDA Issues Class I Recall of Cardiovascular Diagnostic Tests

Kristin J. Kelley, CardioExchange Staff

The FDA announced on Wednesday a Class I recall of several lots of cardiovascular diagnostic tests aiding in the triage of heart failure, MI, and pulmonary embolism. According to the agency, the affected products do not provide the precision described in the package insert, which could lead to potentially fatal false-positive and false-negative test results.

The manufacturer specifically warned about an increased frequency of troponin I results >0.05 ng/mL that, on retesting, are actually below that level. Over 98,000 test kits could be defective, says the FDA.

The manufacturer is advising consumers to stop using the tests immediately and discard them. See this recall notice for the full list of affected products.

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July 12th, 2012