FDA designates recall of troponin tests producing false-negative MI results as class I
Key takeaways:
- Certain blood tests have been recalled due to risk for false negative or falsely low cardiac troponin levels.
- The FDA designated the recall as serious due to the risks of a missed or delayed MI diagnosis.
The FDA announced that it has designated a recall of blood tests for cardiac troponin shown to produce false negatives for MI as class I, the most serious kind.
On May 25, Quidel Cardiovascular Inc. recalled its cardiac panels (Quidel Triage Cardiac Panel; Quidel Triage Cardiac Panel, Troponin I; and Quidel Triage Cardiac Panel, CK-MB and Troponin I) after it received reports of inaccurate tests showing lower-than-expected troponin levels, according to an alert issued by the FDA.
A false negative or falsely low cardiac troponin test can cause missed or delayed diagnoses of MI, putting patients — especially those with silent MI, which can only be diagnosed via changes in cardiac troponin levels; those with unusual or atypical symptoms; and those with non-STEMI — at risk for death or serious injury, the FDA stated in the alert.
The recall affects 7,799 products distributed on or after November 1, 2022, and the company has received 41 complaints but no reports of deaths or injuries related to the issue, according to the alert.
Health care personnel using the product are advised to discontinue its use and switch to an alternative product or send patients to another facility that has alternative products, the FDA stated in the alert.
If patients can be diagnosed with an alternative product, then the Quidel products should be discarded, but if alternative methods and testing sites are not available, the recall notice included steps on how to proceed with use of the affected Quidel products, including flagging all negative results as potentially false; performing serial sampling; and analyzing the results in context with the patient’s risk factors, presentation, ECG results and imaging results, according to the FDA alert.
Read more about