The California-based manufacturer of diagnostic healthcare products, QuidelOrtho, has a Class I recall on almost 8,000 faulty blood tests that inform doctors if a patient is at risk or having a heart attack.
The Triage Cardiac Panel blood tests show doctors low levels of troponin, a protein that signifies that the heart is damaged. The tests present results in a quick manner — within half an hour, meaning many emergency rooms used the device for rapid results. Seeing the low levels means patients are not at risk of having a heart attack, however, the recalled tests were showing a false negative, putting patients at risk for diagnosis or treatment.
In May, QuidelOrtho contacted health systems to halt all usage of the blood tests. The company has received 41 complaints but there have been no injuries or deaths so far.
The FDA released a warning on July 17 saying the recall was "serious," and that those most at risk are patients with zero or abnormal heart attack symptoms. QuidelOrtho believes the error is due to a "raw material issue," as is stated in their recall record.
For now, the company advises all hospitals and doctors to use a different testing method or try multiple blood panel tests to confirm low troponin levels.
This isn't the first time the company has had a product recalled. In 2021, the Lyra PCR COVID-19 test issued false negatives on more than 18,000 test kits.