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.
About the Author Reprints
Exciting news! STAT has moved its comment section to our subscriber-only app, STAT+ Connect. Subscribe to STAT+ today to join the conversation or join us on Twitter, Facebook, LinkedIn, and Threads. Let's stay connected!
To submit a correction request, please visit our Contact Us page.