troponin testing
QuidelOrtho Recalls Triage Cardiac Panels Due to False Negative Results
The FDA has identified this as a Class I recall, the most serious type of recall, as use of these devices may cause serious injury or death.
Although there is still demand for the company's COVID-19 products, it has also launched tests for cardiovascular disease, Alzheimer's, and more.
The company, which received CE marking for its high sensitivity troponin I assay and Atellica VTLi Patient-side Immunoassay Analyzer, plans to enter the US market.
Ortho Clinical Diagnostics Receives Health Canada Approval for High Sensitivity Troponin I Assay
Ortho's assay, which aids in quickly and accurately diagnosing heart attacks, runs on its new Vitros XT 7600 Integrated System, among other Ortho systems.
A Roche executive said he expects essentially all the firm's US troponin customers will convert to the high-sensitivity assay over the next two to three years.