NEW YORK – QuidelOrtho has recalled three Quidel Triage Cardiac Panel products after reports of inaccurate tests showing lower-than-expected troponin levels in samples. The US Food and Drug Administration has identified the recall as Class I, the most serious type, as use of these devices could cause serious injury or death.
The recalled products are the Quidel Triage Cardiac Panel, the Quidel Triage Cardiac Panel Troponin I, and the Quidel Triage Cardiac Panel CK-MB and Troponin I with product codes 97000HS, 97021HS, and 97022HS. The panels were distributed beginning Nov. 1, 2022, and the recall includes a total of 7,799 devices in the US.
Continued use of these products without appropriate mitigations could cause serious injury or death, according to the FDA.
The Quidel Triage Cardiac Panels are blood tests that detect creatine kinase MB or CK-MB, myoglobin, and troponin I in blood or plasma samples to diagnose myocardial infarction, otherwise known as a heart attack, as well as other life-threatening injuries to the heart muscle.
A falsely low or false negative troponin level may cause a delayed or missed diagnosis of myocardial infarction, the FDA said in its recall notice. This poses a risk to people who experience a silent heart attack with no other symptoms, those who have unusual or atypical symptoms, and those with non-ST-segment elevation myocardial infarction (NSTEMI), the FDA also said.
QuidelOrtho sent an Urgent Product Correction Notification on May 25, and on July 12 sent an updated Notification to Customers instructing them to immediately discontinue use of this product and use an alternate method or send patients to another local testing site utilizing an alternate method and throw away all unused Quidel test kits.
If an alternative method is not available, customers should 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, and keep patients on site until at least three negative troponin values have been obtained.
QuidelOrtho has so far reported 41 complaints related to the cardiac panels but no injuries or deaths.
Shares of QuidelOrtho on the Nasdaq were down approximately 2 percent Monday morning at $83.59.