Quidel Triage Cardiac Panel Recall Issued for Blood Tests Used To Identify Heart Attacks, Due to Inaccurate Results

The FDA warns that inaccurate results from the recalled blood tests could lead to extensive heart damage, severe injury or death.

Nearly 8,000 blood tests used to detect heart attacks are being recalled, due to a risk that the kits may provide inaccurate results, which may lead to a misdiagnosis or incorrect treatment for potentially life-threatening cardiac injuries.

The U.S. Food and Drug Administration (FDA) posted information about a Quidel Triage Cardiac Panel recall this week, warning healthcare professionals to stop using the test kits immediately, following reports of the devices failing to detect elevated levels of proteins and enzymes present in the blood when someone is having a heart attack.

Quidel Triage Cardiac Panels are blood tests commonly used in the emergency room setting to alert healthcare professionals that a patient is having a heart attack. They are designed to rapidly identify elevated levels of enzymes and proteins, including troponin, released into an individual’s blood during a cardiac event.

Through the ability to quickly identify these elevated markers in the blood, healthcare professionals can immediately diagnose a heart attack and begin the proper life-saving treatment.

Emergency Room Heart Attack Blood Tests May Result in Delayed Treatment

The FDA warns that an inaccurate troponin level reading can cause a misdiagnosis or failure to diagnose a heart attack. This may lead to incorrect treatment which could cause serious injury or death. Patients who are suffering from a silent heart attack, or other heart conditions which do not normally present any symptoms, are especially at risk of sustaining life-threatening injuries to the heart.

While no injuries or deaths have been reported in relation to the recall, the medical device manufacturer, Quidel Cardiovascular Inc. (QuidelOrtho), issued the recall after becoming aware of at least 41 incidents involving the panels producing false or negative readings.

The recall impacts approximately 7,799 Quidel Triage Cardiac Panel, Quidel Triage Cardiac Panel: Troponin I, and Quidel Triage Cardiac Panel: CK-MB and Troponin I blood tests with product codes 97000HS, 97021HS, and 97022HS. The cardiac panels were distributed in the U.S. from November 1, 2022 until May 25, 2023.

QuidelOrtho sent an urgent medical device correction notification letter to customers on May 25, as well as an updated notification letter on July 12, which explained the problems with the devices, and warned health care professionals to immediately discontinue using the inaccurate panels. The manufacturer recommends providers use an alternative testing method, or refer their patients to another testing facility that can utilize alternative testing methods and produce accurate results.

The FDA has classified the action as a Class I recall, indicating it is the most serious of its kind. Officials are warning that heart attacks, or myocardial infarctions, require early detection and intervention in order to effectively protect the heart muscle from damage, and that failure to do so may result in serious injury or death.

Customers with additional questions or concerns are being asked to contact QuidelOrtho by phone at 858-552-1100, or by contacting their local QuidelOrtho Technical Solutions Center.

The FDA encourages consumers and health care professionals to report any adverse reactions or issues experienced while using the medial devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using the online reporting form.