Quidel Cardiovascular Inc. is recalling the Quidel Triage Cardiac Panel after reports of inaccurate tests showing lower-than-expected troponin levels in samples.
The Quidel Triage Cardiac Panel is a blood test that detects amounts of specific enzymes (creatine kinase MB or CK-MB) and proteins (myoglobin and troponin I) in blood or plasma samples.
The test is used to help doctors quickly diagnose when someone is experiencing a heart attack (myocardial infarction) and other life-threatening injuries to the heart muscle. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
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. 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 (NSTEMI).
QuidelOrtho reports 41 complaints, no injuries, and no deaths related to this issue.
On May 25, 2023, QuidelOrtho sent an Urgent Product Correction Notification and on July 12, 2023 sent an updated Notification to Customers. These letters included the recommendation to immediately discontinue use of this product and use an alternate method, or send patients to another local testing site utilizing an alternate method.