On 18 June 2023, the FDA released a Class I recall on the Quidel triage cardiac panel. A Class I recall is issued when a device, if no action is taken, may lead to serious injury or death.
There were numerous complaints around troponin detection, as the test showed lower-than-expected troponin levels. This could lead to delayed or missed diagnosis of myocardial infarctions, more commonly known as heart attacks, as troponin is released into the bloodstream during a heart attack.
GlobalData’s stock keeping unit (SKU) tracker shows that the triage cardiac panel dominates the multi-parameter cardiac marker tests market in the US, with almost 100% of the market from January 2014 to February 2023. The SKU tracker covers 1,300 US hospitals, 450 distribution centers, 250 physician offices and 380 clinics across the US.
In 2022, QuidelOrtho’s revenue was split among different cardiac marker tests, and showed that the triage cardiac panel made up 1.87% of US revenue, compared to the company’s BNP test, which contributed 88.95%. Based on the whole cardiac marker test market in the US, multi-parameter tests contribute only 0.38% of the market value. Thus the triage test recall will not greatly impact the total cardiac marker tests market nor QuidelOrtho’s revenue in the market, but will be detrimental to the multi-parameter segment, as the triage test contributed 100% of test revenue in 2022.