US-based diagnostics company QuidelOrtho is in hot water with the US Food and Drug Administration (FDA) after the agency hit the company’s recall of its faulty blood tests with a Class I tag, meaning continued use of the products, without actions being taken, could cause serious injury or death.
The company initiated a recall of nearly 8,000 devices in May 2023 after receiving reports that the Quidel Triage Cardiac Panel was not correctly measuring a specific biomarker.
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The fluorescence immunoassay, which QuidelOrtho says has a negative predictive value of 99.9%, detects amounts of specific enzymes and proteins in the blood, which fluctuate when a patient experiences a heart attack or other serious myocardium-related conditions.
The test can produce results in around 20 minutes, according to the company, and is used by doctors to quickly diagnose such events in a point-of-care setting.
One of the parameters detected by the test is troponin – a protein released into the bloodstream during a heart attack. However, QuidelOrtho has received 41 complaints that the panel is showing lower-than-expected troponin levels, meaning the test is faulty.
In a recall alert, the FDA stated: “A falsely low or false negative troponin level may cause a delayed or missed diagnosis of myocardial infarction – a serious, potentially fatal condition that requires the earliest detection possible to treat and protect the heart muscle effectively.”
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By GlobalDataThe agency went on to say that although there have currently been no injuries or deaths, the faulty test poses a greater risk to patients who experience a ‘silent’ myocardial infarction where no other symptoms are displayed and to those who have unusual symptoms.
In a letter to customers, QiudelOrtho said they should stop using the test and swap it with an alternative product. If no alternative is available, patients should be sent to another local testing site where tests are available.
There are 16,194 Quidel Triage Cardiac Panel devices in commerce around the world, as per the FDA database.
