leisure time -WSS

leisure time

author：focus 2025-10-01 17:20:49 - browse：658

Transparent plastic divider on the reception desk in the hospital admission department with red lettering emergency. — Adobe

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.

Related: With Wegovy and Ozempic’s success, can device makers keep up in the race to treat obesity?

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.

Previous article： ChatGPT in medicine: STAT answers readers' burning questions
Next article： Addressing health care workers' trauma can help fight burnout

focus

hotspot

WSS

Roivant's CEO is a star, but biotech's black hole persists

STAT Summit: How researchers deal with rejection

Investigation reveals sickle cell patients pressured into sterilizations

UnitedHealth, Optum discontinue NaviHealth name

UnitedHealth argues against case alleging wrongful AI care denials

UnitedHealth argues against case alleging wrongful AI care denials

hotspot

leisure time

Related: With Wegovy and Ozempic’s success, can device makers keep up in the race to treat obesity?

focus

23andMe had bad news about my health. I wish a person had delivered it

How AI can help patients find reliable information about doctors

In Memoriam: Notable people who died in 2023

For longer

In Memoriam: Notable people who died in 2023

Cue Health, Covid

Guidelines to prevent youth baseball injuries need more muscle

STAT Readout Newsletter: Biotech news today

ChatGPT in medicine: STAT answers readers' burning questions

Health tech investors get more selective as pandemic boom fades

focus

Cytokinetics sells Royalty Pharma a share of its heart drug for up to $575M

Readout Newsletter: AstraZeneca's CEO, Roivant's $5 billion deal

Investigation reveals sickle cell patients pressured into sterilizations

Cytokinetics CEO Robert Blum is on my Worst CEO shortlist again

Addressing health care workers' trauma can help fight burnout

Bird flu surveillance in wastewater gets boost from consortium

focus

focus

hotspot

hotspot