The FDA is calling to attention a Class I recall of Quidel Triage Cardiac Panels by Quidel Cardiovascular Inc. (QuidelOrtho) because the device may produce false negative troponin results, which could potentially lead to a delayed diagnosis or a missed myocardial infarction.
The recall, which was initiated by the firm on May 25, 2023, was identified by the FDA as Class I, the most serious type, indicating that use of the product could lead to serious injuries, or even death.
Officials say 7,799 devices that were distributed across the U.S. since November 1, 2022 are affected. Those devices include Quidel Triage Cardiac Panel, Quidel Triage Cardiac Panel, Troponin I, and Quidel Triage Cardiac Panel, CK-MB and Troponin I, under Product Codes 97000HS, 97021HS, and 97022HS.
A blood test that detects levels of certain enzymes (creatine kinase MB or CK-MB) and proteins (myoglobin and troponin I) in blood or plasma samples, the Quidel Triage Cardiac Panel is indicated to aid doctors in quickly diagnosing when a patient is suffering “a heart attack (myocardial infarction) or other life-threatening injuries to the heart muscle.”
The company took action after being alerted to reports of the Quidel Triage Cardiac Panel producing inaccurate tests which showed lower-than-anticipated troponin levels in samples. A falsely-low, or false negative troponin level may cause a delayed diagnosis of myocardial infarction, or cause it to be missed. These oversights could then place a patient in a fatal condition, which would necessitate the earliest possible detection to effectively treat and protect heart muscle. The situation would be especially risky for patients suffering a silent myocardial infarction, in which they are exhibiting no other symptoms. People who experience unusual and/or atypical symptoms, as well as “those with non-ST-segment elevation myocardial infarction (NSTEMI)” would also be at the most risk.
To date, QuidelOrtho has been made aware of 41 complaints connected to the problem. No injuries or deaths have been reported.
An Urgent Product Correction Notification sent to users May 25, 2023, in addition to an updated letter issued July 12, 2023, outlined a list of recommended actions:
Immediately cease use of the affected product, and either switch to an alternative method or refer patients to another area testing facility that utilizes an alternative method.
- In the event that an alternate method or alternate local testing site is unavailable, consult the Required Actions* on ways to reduce the potential impact on patients who continue to use the product.
*Required Actions for Customers Continuing Use of Affected Product Lots
- In the event that an alternate method or another local site using an alternative method is available, dispose of all unused Quidel test kits.
- In the event that an alternate method or local site with an alternative method is not available, carefully adhere to following steps, where applicable, to minimize patient risk:
- Note ALL negative results reported to clinicians as potentially inaccurate until new, unaffected product is made available
- When troponin results are either below or close to the cutoff, and myocardial infarction is suspect, refer to results from an alternate clinical laboratory analyzer or an alternate testing location
- Conduct serial sampling: Collect at least three negative troponin values before releasing patients
- Consider all Triage troponin results along with “the patient’s risk factors, clinical presentation, EKG, and other imaging” results.
- When monitoring a patient’s troponin rise or fall pattern, refer to recommendations outlined by the American College of Cardiology, the European Society of Cardiology, and the Fourth Universal Definition of Myocardial Infarction.
- When experiencing problems with Proficiency testing, consult the local Technical Solutions Center.
- In the event that the product was distributed to those outside of a given facility, ensure that the Urgent Product Correction Notification (and all updates) are forwarded to relevant personnel.
Those with recall-related questions can reach QuidelOrtho at 858-552-1100 or via their local QuidelOrtho Technical Solutions Center.
As the FDA continues to oversee this recall, healthcare professionals and consumers alike are encouraged to report adverse experiences to the agency’s MedWatch program.
Have you or a loved one suffered an adverse health outcome from using a compromised medical device? After a traumatic, possibly life-threatening medical event, your family deserves fair compensation. Speak to a compassionate attorney at TruLaw to learn how we can help you secure the best outcome and hold negligent parties responsible. Connect with us online or take our free Instant Case Evaluation ℠.