hotspot -WSS

hotspot

author：focus 2025-10-02 05:38:53 - browse：5791

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： Psychedelics group wrestles with new pharma identity
Next article： CDC marks new Covid

WSS

Influencer to be charged after chaos erupts in New York City's Union Square

How to bring more disabled researchers into academia

UnitedHealth quietly bought dozens of outpatient centers

What it’s like to watch children die of measles

TytoCare raises $49 million to build out AI

The Readout: Amylyx, Alumis, and Lundbeck drug updates

knowledge

hotspot

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

leisure time

Activists slam private health insurers over coverage restrictions

What it’s like to watch children die of measles

Novavax promises a turnaround & Lilly roils the obesity market

My superpower is killing ticks

Novavax promises a turnaround & Lilly roils the obesity market

My superpower is killing ticks

Dobbs anniversary: the lost opportunity of abortion as health care

In surprise move, FDA calls for advisory committee on Lilly's Alzheimer's drug

Bright Health sells Medicare Advantage business to Molina

IVF, abortion rights issues kick off Biden’s State of the Union

explore

Wild otter attack leads to woman being airlifted to hospital, 2 others treated for injuries

White House drug shortage group privately met with industry

NEJM study link tiny plastics in blood vessels to heart problems

Biden calls for immediate release of Niger's president amid apparent coup

ProMED, early warning system on disease outbreaks, in peril

CDC: Uninsured rate hit 'record low' right as states cut Medicaid

entertainment

hotspot

leisure time

Wikipedia