United States: The U.S. Food and Drug Administration (FDA) on July 17, 2023, announced that it has asked Quidel Cardiovascular Inc. to recall certain blood tests used to detect myocardial infarctions. The FDA has labelled this as a Class I recall, which is a most serious type of recall, and said that using these devices can cause injuries or death.  The United States Food and Drug Administration (FDA) states that reports of blood tests indicating artificially low levels of troponin, are particularly concerning for patients who suffer from ‘quiet’ heart attacks.

The Quidel Triage Cardiac Panel is a blood Test for Diagnosis of Myocardial Infarction (QTIA). The tests use a blood sample and can deliver results in about 20 minutes. It is designed to detect concentrations of various enzymes and proteins that are associated with an increased risk of heart attacks or other life-threatening cardiac events. Due to numerous reports of incorrect tests, the recall is effective.

The Fluorescence Immunoassay (FISA) has a negative predictive value of 99.9%, according to Quidel Ortho. It analyzes the number of certain enzymes and proteins present in the blood during a patient's cardiac event or other severe myocardial infarction-related conditions.

FDA Advisory said, “A falsely low or false negative troponin level may cause a delayed or missed diagnosis of myocardial infarction—a serious, potentially fatal condition that requires the earliest detection possible to treat and protect the heart muscle effectively. This poses a particular risk to people who experience a silent myocardial infarction with no other symptoms, those who have unusual or atypical symptoms, and those with non-ST-segment elevation myocardial infarction.”

The company recall included 7,799 devices which are labeled Quidel Triage Cardiac Panel, Quidel Triage Cardiac Panel-Troponin I or Quidel Triage Cardiac Panel-CK-MB and Troponin I. QuidelOrtho first initiated the recall on May 25, 2023, sending Urgent Product Correction Notifications to all customers. The company then sent an additional update on July 12, 2023.

Nearly 8000 cardiac panel blood tests were cancelled after 41 reports of inaccurate test results that pose the risk of missing a heart attack diagnosis. There are 16,194 Quidel Triage Cardiac Panel devices commerce around the world.

Customers were advised to discontinue the use of the devices "immediately" and to either utilize an alternative method of testing or to send patients to an alternative testing site in the local area. In cases where an alternative testing method is not available or an alternative testing site is not available, customers utilizing the devices are advised to report "all negative results" to clinicians as potentially inaccurate.

According to TechSci Research, medical test which is recalled by U.S. FDA is used to determine heart attack, which is also known as acute coronary syndrome (ACS) caused by significant blockage in the coronary arteries. This faulty heart attack test represents that one blood test alone doesn’t determine the risk of heart disease. A ST elevation myocardial infarction (STEMI) is the most serious type of heart attack where there is a long interruption to the blood supply. However, a Non-STEMI can be less serious than a STEMI because the supply of blood to the heart may be only partially, rather than completely, blocked.