QuidelOrtho recalls 8,000 faulty blood tests over missed heart attack diagnosis

QuidelOrtho has recalled nearly 8,000 potentially faulty blood tests meant to help doctors quickly determine whether a patient is having a heart attack.

The tests inaccurately showed low levels of troponin, a protein that indicates damage to the heart. A false negative could lead doctors to mistakenly conclude their patient is not having a heart attack, delaying diagnosis or treatment when time is of the essence.

The device maker, which also sells products like the QuickVue Covid-19 antigen test, sent letters to health systems in May telling them to immediately stop using the test. The Food and Drug Administration classified the recall as serious, because problems with the product could result in serious injury or death. QuidelOrtho has reported 41 complaints, but no injuries or deaths so far.

The tests, which use either a blood or plasma sample, promise to return results in under half an hour. They are used in emergency rooms to triage patients suspected of having a heart attack.

The FDA said the patients most at risk are those with zero or abnormal heart attack symptoms, for whom a diagnosis would be easy to miss without an accurate lab test.

The company advised using a different testing method to detect heart attacks. If none are available, doctors should be extra wary of the blood panel’s readings, perform multiple tests to confirm low troponin levels, and also reference data from EKGs and other imaging.

San Diego-based QuidelOrtho said the error is due to a “raw material issue” in its recall record. The issue caused the test to falsely pick up 30% less troponin than is present. The company did not respond to STAT’s request for more information on the error.

The test maker’s last serious recall was in 2021 for reports of false negatives from its Lyra PCR Covid-19 test when used with certain lab equipment. The notice impacted more than 18,000 test kits. STAT