QuidelOrtho's recall of potentially faulty heart attack blood tests lands FDA Class I tag

QuidelOrtho is recalling thousands of blood tests used to help quickly diagnose myocardial infarctions and other heart conditions.

The company began recalling certain lots of the Quidel Triage Cardiac Panel at the end of May, and in a notice on Monday, the FDA gave the recall a Class I label—the regulator’s most serious rating, denoting a heightened risk of injury or death.

The panel is designed for rapid, point-of-care use. It requires either a plasma or whole-blood sample to measure creatine kinase MB, myoglobin and troponin I in the blood, and it can churn out results within about 20 minutes.

According to its maker, the test boasts a negative predictive value of 99.9%, meaning that doctors can use its results to quickly and confidently rule out likely negative cases of myocardial infarction, more commonly known as a heart attack.

QuidelOrtho began the recall after receiving reports that some of the tests were producing inaccurately low measurements of the protein troponin. Troponin levels are typically elevated in the hours after a heart attack, so falsely low results could prevent doctors from diagnosing the condition as quickly as possible.

As the FDA pointed out in its notice, that inaccuracy could be particularly harmful to people experiencing myocardial infarctions without symptoms or with abnormal signs of the infection, for which a test like QuidelOrtho’s may be one of the only ways to detect the heart attack.

To date, the company has reported 41 complaints related to the issue, with no reports of injury or death.

The recall spans more than 16,000 of the Quidel Triage Cardiac Panels distributed around the world since the start of November 2022, per its entry in the FDA’s recall database. Almost half of the recalled tests—nearly 7,800—were distributed in the U.S.

In letters sent to healthcare providers who may have some of the recalled tests in stock, QuidelOrtho recommended that they immediately stop using the affected panels, throw away all unused test kits and use an alternative diagnostic. If no other test is available at their healthcare facility, they should send patients to another site that does have an alternative test available.

If there isn’t another test available at their facility or any nearby testing sites, healthcare providers may continue to use the recalled tests until they’re able to get their hands on an alternative—but with certain precautions. For one, they should alert clinicians that any negative results from the tests could be potentially inaccurate. For another, QuidelOrtho recommends that they perform the tests repeatedly, waiting to release patients until the low troponin results have shown up at least three times.

In the meantime, the company also suggested that clinicians take each patient’s risk factors and ECG and other imaging results into account alongside the test results to diagnose or dismiss a potential case of myocardial infarction and that they follow recommended guidelines to watch for the typical rise and fall of troponin levels that occurs after a heart attack.