Dive Brief:
- QuidelOrtho’s recall of a test to detect heart attacks was labeled Class I by the Food and Drug Administration, the most serious type of recall, the agency said in a Monday notice.
- The San Diego-based diagnostic manufacturer flagged a problem with the tests in late May after receiving reports that the tests showed lower than expected troponin levels, which could result in delayed or missed diagnosis of a heart attack.
- The recall affects nearly 7,800 tests, and QuidelOrtho is instructing clinicians to immediately discontinue using the product, and instead use a different test or send patients to another testing site.
Dive Insight:
Quidel’s Triage Cardiac Panel is intended to help diagnose heart attacks. The test uses a blood sample, and can deliver results in about 20 minutes, according to the company’s website.
It is important to detect heart attacks quickly to treat and protect the heart muscle, the FDA said in its notice.
After Quidel received reports that tests were showing lower than expected levels of troponin — a type of protein that can signal heart damage when certain levels are detected in the bloodstream — the company advised clinicians to stop using the test. The problem could pose a higher risk to people who experience a “silent” heart attack with no other symptoms, people who have unusual symptoms, and heart attacks without an easily identifiable electrical pattern, the FDA said in its notice.
“Continued use of these products without appropriate mitigations could cause serious injury or death,” the agency added.
So far, QuidelOrtho has received 41 complaints, and no reports of injuries or deaths related to the test.
The company recommended that clinicians stop using its tests and switch to an alternate test method, or send patients to another testing site. If that’s not possible, then QuidelOrtho recommended flagging all negative results as possibly inaccurate, keeping patients until they’ve received at least three negative tests. The company also recommended considering other information in making a diagnosis, including a person’s risk factors, clinical presentation and imaging.