The U.S. Food and Drug Administration (FDA) on July 19 issued a letter to health care providers, recommending that alternative testing methods or alternative testing sites be used for the Quidel Triage Cardiac Panel.

Quidel Cardiovasacular Inc. has recalled certain lots of the Quidel Triage Cardiac Panel due to reports of tests providing inaccurate, lower than expected troponin levels in samples. As a false negative test may result in a delayed or misdiagnosed myocardial infarction, the agency has identified this as a Class I recall, where use of these devices may cause serious injuries, serious health consequences or death.

Access the full FDA letter for additional recommendations for health care providers, laboratory personnel and facilities along with instructions for reporting problems with a device.

Clinical Topics: Cardiovascular Care Team

Keywords: Diagnostic Errors, Myocardial Infarction, Triage, Troponin, United States Food and Drug Administration, United States, ACC Advocacy

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