July 18, 2023 — The U.S. Food and Drug Administration (FDA) has issued a Class I recall on Quidel Cardiovascular is recalling its Quidel Triage Cardiac Panels for risk of false negative troponin results that could cause delayed diagnosis or missed myocardial infarction.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
- Quidel Triage Cardiac Panel
- Quidel Triage Cardiac Panel, Troponin I
- Quidel Triage Cardiac Panel, CK-MB and Troponin I
Product Lots: See Medical Device Recall Database entry
Distribution Dates: Beginning November 1, 2022
Devices Recalled in the U.S.: 7,799
Date Initiated by Firm: May 25, 2023
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.
Reason for Recall
Quidel Cardiovascular Inc. (QuidelOrtho) is recalling the Quidel Triage Cardiac Panel after reports of inaccurate tests showing lower than expected troponin levels in samples.
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).
Continued use of these products without appropriate mitigations could cause serious injury or death.
QuidelOrtho reports 41 complaints, no injuries, and no deaths related to this issue.
Who May be Affected
- People who have suspected myocardial infarction whose troponin levels are tested using the Quidel Cardiac Triage Panel.
- Health care personnel assessing patients for possible myocardial infarction using the Quidel Cardiac Triage Panel.
What to Do
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 following recommended actions for customers and users:
Immediately discontinue use of this product and use an alternate method, or send patients to another local testing site utilizing an alternate method. If an alternate method or alternate local testing site is not available, see Required Actions for recommendations on how to mitigate potential patient impact when continuing use of the product.
Required Actions for Customers Using Impacted Product Lots
- If you have an alternate method, or another local testing site using an alternative method is available for testing, please throw away all unused Quidel test kits.
- If you do not have an alternate method, or another local testing site with an alternative method is not available, please follow these steps, as applicable, to minimize patient risk.
- Flag ALL negative results reported to clinicians as possibly inaccurate until lots of unaffected product are available.
- Use results from an alternate clinical laboratory analyzer or alternate testing site when troponin results are below or close to the cutoff and myocardial infarction is suspected.
- Perform serial sampling. Keep patients until at least three negative troponin values have been obtained.
- Use all Triage troponin results in conjunction with the patient’s risk factors, clinical presentation, EKG, and other imaging.
- Consider recommendations by the American College of Cardiology, guidelines from the European Society of Cardiology, and the Fourth Universal Definition of Myocardial Infarction for monitoring a patient for a rise or fall pattern of troponin.
- If you are experiencing issues with Proficiency testing, contact your local Technical Solutions Center.
- Forward this notification if the product was distributed outside of your facility.
Customers with questions should contact QuidelOrtho at 858-552-1100 or contact the local QuidelOrtho Technical Solutions Center.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.