The US Food and Drug Administration (FDA) is sounding the alarm for health care providers and facilities using the Quidel Triage Cardiac Panel manufactured by Quidel Cardiovascular Inc. Recent reports revealed inaccuracies in troponin levels, potentially leading to misdiagnoses and inadequate clinical interventions for heart attack cases. 

On May 25, 2023, Quidel Cardiovascular Inc issued an Urgent Product Correction Notification recalling specific lots of the Quidel Triage Cardiac Panel. The decision came after receiving reports of inaccurate and lower-than-expected troponin levels in samples. Troponin tests play a crucial role in diagnosing myocardial infarction, especially non-ST-segment elevation myocardial infarction (NSTEMI), and guiding appropriate clinical interventions to prevent heart muscle damage.

Falsely low or false negative troponin test results can have severe consequences for patients’ health. Timely diagnosis of a heart attack becomes challenging, leading to delayed or inadequate medical interventions. Identifying patients at risk for myocardial infarction and initiating immediate care is vital for minimizing cardiac damage and preventing potential fatalities. The inaccurate results from the affected Quidel Triage Cardiac Panel could jeopardize patient outcomes and place their lives at risk.

FDA’s Class I Recall and Recommendations

The FDA categorizes the Quidel Triage Cardiac Panel recall as Class I, the most critical type of recall. Health care providers, laboratory personnel, and facilities currently using the affected product are advised to cease its use immediately. Instead, the FDA recommends adopting alternative testing methods to ensure accurate diagnoses.

For those without available alternative testing methods locally, QuidelOrtho’s May 25, 2023, Urgent Product Correction Notification provides interim measures to mitigate risks. Clinicians must flag all negative results as possibly inaccurate until unaffected product lots are accessible. Additionally, using results from an alternate clinical laboratory analyzer when troponin levels are below or close to the cutoff is advised in suspected myocardial infarction cases.

Health care providers, laboratories, and facilities are urged to follow the recommendations set forth by the American College of Cardiology (ACC), European Society of Cardiology (ESC) guidelines, and the Fourth Universal Definition of Myocardial Infarction. Implementing these guidelines alongside alternative testing methods can help monitor patients for a rise or fall pattern of troponin, which is crucial in assessing their cardiac health accurately.

Staying Informed and Reporting Adverse Events

The FDA assures the public that alternative tests from other suppliers are available, minimizing the likelihood of shortages. Nevertheless, the FDA is actively working with QuidelOrtho to investigate and identify contributing factors to this issue.

To ensure patient safety, the FDA encourages users to report any adverse events or suspected adverse events related to the Quidel Triage Cardiac Panel. Reporting can be done voluntarily through MedWatch, the FDA Safety Information, and Adverse Event Reporting program, or through the applicable Medical Device Reporting (MDR) regulations for device manufacturers and user facilities.