Nearly 8,000 cardiac panel blood tests have been recalled after 41 reports of inaccurate test results that pose the risk of missing a heart attack diagnosis, the FDA said July 17.
Quidel Cardiovascular, a San Diego-based business of global medical device company QuidelOrtho, is recalling 7,799 Quidel Triage Cardiac Panels in a Class I recall — the most serious type because of the risk of serious injury or death.
No injuries or deaths have been reported in relation to this recall.
The company received complaints of inaccurate tests showing lower than expected troponin levels in samples, which could hinder an accurate diagnosis of a heart attack.
"This poses a particular risk to people who experience a silent myocardial infarction with no other symptoms, those who have unusual or atypical symptoms, and those with non-ST-segment elevation myocardial infarction," the FDA said.